Not provided
Not provided
Not provided
Not provided
Terminated 9/24/23 at 85% target enrollment due to slow accrual of subjects. The decline in enrollment was attributed to changing surgical demographics (higher MELD, more DCD grafts, and increasing use of Normothermic Perfusion technology).
Not provided
Not provided
| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| The Methodist Hospital Research Institute | OTHER |
Not provided
Not provided
Not provided
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.
This study is a randomized controlled trial of mild hypothermia during liver transplantation to provide protection from AKI. Participants will be randomized to normothermia (36.5-37.5 °C) versus mild hypothermia (34-35 °C) during a portion of the liver transplant operation. The protocol is based on preliminary data from rodent models showing that hypothermia protects the kidneys from ischemia-reperfusion injury, as well as studies in deceased organ donors showing that cooling improves post-transplant organ function. Temperature will be maintained with standard techniques plus a minimally-invasive esophageal cooling device that is approved by the U.S. Food and Drug Administration. The investigators hypothesize that mild hypothermia will reduce the incidence and severity of AKI after liver transplantation(LTx). Standard surrogates (e.g., change in serum creatinine, need for initiation of dialysis) and biomarkers will be used to assess the severity of kidney injury.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hypothermia & Esophageal cooling/warming device | Experimental | The target core temperature is 34-35 °C. |
|
| Normothermia & Esophageal cooling/warming device | Active Comparator | The target core temperature is 36.5-37.5 °C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal cooling/warming device | Device | The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury (AKI) | Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as the most recent value obtained prior to liver transplantation. | 72 hours from the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the Stages of Acute Kidney Injury (AKI) | The International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7), will be used to define the stage of AKI (Stage 1, 2, or 3). The distribution of the stages of AKI within 72 hours after liver transplantation. The stages of AKI are defined as follows based on the serum creatinine (sCr): AKI Stage 1: increase in sCr ≥ 0.3 mg/dL, or an increase in sCr ≥ 1.5-fold and ≤ 2-fold from baseline. AKI Stage 2: increase in sCr > 2-fold and ≤ 3-fold from baseline. AKI Stage 3: increase in sCr > 3-fold from baseline, or sCr ≥ 4.0 with an acute increase of ≥ 0.3 mg/dL, or initiation of renal replacement therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Product Transfusions | The number of units of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate transfused during surgery. We had originally proposed to measure up until 72 hours after surgery, but we were not able to collect this data at all centers. Therefore, only blood product transfusions during surgery are reported. | During surgery |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael P Bokoch, MD, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| University of Colorado Anschutz Medical Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26222557 | Background | Niemann CU, Feiner J, Swain S, Bunting S, Friedman M, Crutchfield M, Broglio K, Hirose R, Roberts JP, Malinoski D. Therapeutic Hypothermia in Deceased Organ Donors and Kidney-Graft Function. N Engl J Med. 2015 Jul 30;373(5):405-14. doi: 10.1056/NEJMoa1501969. | |
| 25631669 | Background | Angeli P, Gines P, Wong F, Bernardi M, Boyer TD, Gerbes A, Moreau R, Jalan R, Sarin SK, Piano S, Moore K, Lee SS, Durand F, Salerno F, Caraceni P, Kim WR, Arroyo V, Garcia-Tsao G; International Club of Ascites. Diagnosis and management of acute kidney injury in patients with cirrhosis: revised consensus recommendations of the International Club of Ascites. Gut. 2015 Apr;64(4):531-7. doi: 10.1136/gutjnl-2014-308874. Epub 2015 Jan 28. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were enrolled after liver transplantation was scheduled but before entering the operating room for surgery. Before proceeding with randomization, it was necessary for the attending surgeon to verify that the liver graft was suitable for transplantation. If that was not the case, the transplant could be aborted before randomization.
Subjects were recruited between July 2018 and August 2023 from patients scheduled for deceased donor liver transplantation at three transplant centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mild Hypothermia & Esophageal Cooling/Warming Device | The target core temperature is 34-35 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube and is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Mild hypothermia | Other | Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end. |
|
| Normothermia | Other | After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
| 72 hours from the end of surgery |
| Duration of Intensive Care Unit (ICU) Stay | Time after liver transplantation until patient is discharged from the ICU to a regular hospital bed. | Time from end of liver transplant to ICU discharge, approximately 1 to 3 days |
| Duration of Hospital Stay | From the date of liver transplantation until the date patient is discharged from the hospital. | Time from liver transplant to hospital discharge, approximately 1-2 weeks. |
| Patient Survival | From the date of liver transplantation until the date of death from any cause. | up to 1 year |
| Need for Renal Replacement Therapy | Patient is receiving continuous renal replacement therapy or dialysis at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient was on renal replacement therapy). | 72 hours, 30 days, and 1 year. The original protocol specified assessment at 1 week after surgery. However, this data was unable to be collected and we are only able to determine the outcome at 72 hours, 30 days, and 1 year. |
| Persistent Renal Dysfunction | Presence of a reduction in GFR by ≥ 25 mL/min or ≥ 50% from baseline at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient had persistent renal dysfunction). | 90 days and 1 year |
| Serum Neutrophil Gelatinase-associated Lipocalin (NGAL) | Change in serum NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial). | Baseline (start of surgery) and 2 hours after reperfusion of the portal vein |
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) | Change in urine NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial). | Baseline (start of surgery) and 2 hours after reperfusion of the portal vein |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| 19938135 | Background | Niemann CU, Walia A, Waldman J, Davio M, Roberts JP, Hirose R, Feiner J. Acute kidney injury during liver transplantation as determined by neutrophil gelatinase-associated lipocalin. Liver Transpl. 2009 Dec;15(12):1852-60. doi: 10.1002/lt.21938. |
| 29283916 | Background | Kalasbail P, Makarova N, Garrett F, Sessler DI. Heating and Cooling Rates With an Esophageal Heat Exchange System. Anesth Analg. 2018 Apr;126(4):1190-1195. doi: 10.1213/ANE.0000000000002691. |
| 25420865 | Background | Karapanagiotou A, Dimitriadis C, Papadopoulos S, Kydona C, Kefsenidis S, Papanikolaou V, Gritsi-Gerogianni N. Comparison of RIFLE and AKIN criteria in the evaluation of the frequency of acute kidney injury in post-liver transplantation patients. Transplant Proc. 2014 Nov;46(9):3222-7. doi: 10.1016/j.transproceed.2014.09.161. |
| 28255614 | Background | Kellum JA, Zarbock A, Nadim MK. What endpoints should be used for clinical studies in acute kidney injury? Intensive Care Med. 2017 Jun;43(6):901-903. doi: 10.1007/s00134-017-4732-1. Epub 2017 Mar 2. No abstract available. |
| FG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-treat population. Excludes participants that were withdrawn after randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mild Hypothermia & Esophageal Cooling/Warming Device | The target core temperature is 34-35 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube and is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end. |
| BG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Etiology of liver disease | Count of Participants | Participants |
| ||||||||||||||||
| Model for End-stage Liver Disease-Sodium score | This score reflects the severity of liver disease and is used to determine priority for liver transplantation. It is a standard assessment for patients with liver disease calculated from the preoperative serum sodium, total bilirubin, international normalized ratio, and creatinine (or the need for preoperative renal replacement therapy). The scale ranges from 6-40, with higher scores representing more severe liver disease. For additional details and full calculation, please see Kim WR et al. N Engl J Med 2008;359:1018-1026. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Kidney Injury (AKI) | Acute Kidney Injury (AKI) is defined according to the International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7). AKI is defined as an increase in sCr ≥ 0.3 mg/dL within 48 hours, or a percentage increase ≥ 50% from baseline, or the initiation of renal replacement therapy. Baseline creatinine is defined as the most recent value obtained prior to liver transplantation. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Count of Participants | Participants | 72 hours from the end of surgery |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Distribution of the Stages of Acute Kidney Injury (AKI) | The International Club for Ascites (ICA) 2015 criteria, a revision of the Kidney Disease Improving Global Outcome (KDIGO) criteria for patients with cirrhosis (Angeli P, Ginès P, Wong F, Bernardi M, Boyer TD, Gerbes A, et al. Gut. 2015 Apr;64(4):531-7), will be used to define the stage of AKI (Stage 1, 2, or 3). The distribution of the stages of AKI within 72 hours after liver transplantation. The stages of AKI are defined as follows based on the serum creatinine (sCr): AKI Stage 1: increase in sCr ≥ 0.3 mg/dL, or an increase in sCr ≥ 1.5-fold and ≤ 2-fold from baseline. AKI Stage 2: increase in sCr > 2-fold and ≤ 3-fold from baseline. AKI Stage 3: increase in sCr > 3-fold from baseline, or sCr ≥ 4.0 with an acute increase of ≥ 0.3 mg/dL, or initiation of renal replacement therapy. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Count of Participants | Participants | 72 hours from the end of surgery |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Intensive Care Unit (ICU) Stay | Time after liver transplantation until patient is discharged from the ICU to a regular hospital bed. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Median | Inter-Quartile Range | hours | Time from end of liver transplant to ICU discharge, approximately 1 to 3 days |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Hospital Stay | From the date of liver transplantation until the date patient is discharged from the hospital. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Median | Inter-Quartile Range | days | Time from liver transplant to hospital discharge, approximately 1-2 weeks. |
| ||||||||||||||||||||||||||||||
| Secondary | Patient Survival | From the date of liver transplantation until the date of death from any cause. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Count of Participants | Participants | up to 1 year |
| |||||||||||||||||||||||||||||||
| Secondary | Need for Renal Replacement Therapy | Patient is receiving continuous renal replacement therapy or dialysis at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient was on renal replacement therapy). | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Count of Participants | Participants | 72 hours, 30 days, and 1 year. The original protocol specified assessment at 1 week after surgery. However, this data was unable to be collected and we are only able to determine the outcome at 72 hours, 30 days, and 1 year. |
| |||||||||||||||||||||||||||||||
| Secondary | Persistent Renal Dysfunction | Presence of a reduction in GFR by ≥ 25 mL/min or ≥ 50% from baseline at the time of follow-up. If patient died before the indicated follow-up time, the outcome was counted as positive (patient had persistent renal dysfunction). | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Count of Participants | Participants | 90 days and 1 year |
| |||||||||||||||||||||||||||||||
| Secondary | Serum Neutrophil Gelatinase-associated Lipocalin (NGAL) | Change in serum NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial). | Serum for NGAL determination was only collected at the coordinating center. It was not feasible to collect serum for all patients due to research personnel being unavailable during some off-hours and weekend liver transplants. | Posted | Median | Inter-Quartile Range | ng/mL | Baseline (start of surgery) and 2 hours after reperfusion of the portal vein |
| ||||||||||||||||||||||||||||||
| Secondary | Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) | Change in urine NGAL levels from baseline to 2 hours after reperfusion of the portal vein (final - initial). | Urine for NGAL determination was only collected at the coordinating center. It was not feasible to collect urine for all patients due to research personnel being unavailable during some off-hours and weekend liver transplants. | Posted | Median | Inter-Quartile Range | ng/mL | Baseline (start of surgery) and 2 hours after reperfusion of the portal vein |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Blood Product Transfusions | The number of units of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate transfused during surgery. We had originally proposed to measure up until 72 hours after surgery, but we were not able to collect this data at all centers. Therefore, only blood product transfusions during surgery are reported. | Intention-to-treat population. Excludes participants that were withdrawn after randomization. | Posted | Median | Inter-Quartile Range | Units of blood product transfused | During surgery |
|
Adverse events were assessed from the time of enrollment until the end of liver transplantation surgery, with the exception of surgical site infection which was assessed until 2 weeks after surgery. Serious adverse events were assessed until 2 weeks after surgery. Deaths were assessed for up to 1 year (see Outcome Measures: Patient survival).
Adverse events were defined as any untoward or unfavorable event that is outside that normally expected for the clinical course of liver transplantation, as reported by the study clinicians (attending anesthesiologist or surgeon) or the site prinicipal investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mild Hypothermia & Esophageal Cooling/Warming Device | The target core temperature is 34-35 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Mild hypothermia: Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end. | 5 | 86 | 5 | 86 | 15 | 86 |
| EG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. | 7 | 85 | 3 | 85 | 15 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary non-function of the liver | Hepatobiliary disorders | Non-systematic Assessment | Retransplantation within 7 days |
| |
| Inferior vena cava thrombus | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Intraoperative cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Disseminated fungal infection leading to death | Infections and infestations | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding (significant) with refractory severe coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment | Bleeding not attributable to vascular injury. Ongoing clinical coagulopathy, or lab evidence of persistent INR > 4 or fibrinogen < 75 mg/dL, despite aggressive treatment (15 mL/kg FFP, cryo 10 units x 2 doses, and antifibrinolytics). |
| |
| Bleeding, upper gastrointestinal with esophageal temperature management device insertion | Gastrointestinal disorders | Non-systematic Assessment | Blood return > 500mL at time of esophageal temperature management device insertion |
| |
| Hypothermia, severe | General disorders | Non-systematic Assessment | Temperature < 33 deg C for > 30 min |
| |
| Oropharyngeal, dental, or esophageal trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Perforation or damage to esophageal temperature management device | Product Issues | Non-systematic Assessment |
| ||
| Cardiac arrhythmia | Cardiac disorders | Non-systematic Assessment | Intraoperative arrhythmia requiring treatment, excluding bradycardia at the time of liver reperfusion. |
| |
| Myocardial ischemia | Cardiac disorders | Non-systematic Assessment |
| ||
| Surgical bleeding, severe | Injury, poisoning and procedural complications | Non-systematic Assessment | Not attributable to coagulopathy |
| |
| Postreperfusion syndrome | Hepatobiliary disorders | Non-systematic Assessment | Subjective, as reported by attending anesthesiologist |
| |
| Esophageal temperature management device problem | Product Issues | Non-systematic Assessment | Inadequate gastric suction or decompression, or accidental tracheal extubation during manipulation. |
| |
| Electrolytes, overcorrection of hyponatremia | Renal and urinary disorders | Non-systematic Assessment | 1.5 mEq/L/h increase during surgery |
| |
| Portal vein thrombus | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Drug error | Injury, poisoning and procedural complications | Non-systematic Assessment | Cisatracurium concentration higher than expected (10 mg/mL instead of 2 mg/mL) |
| |
| Traumatic central line insertion | Injury, poisoning and procedural complications | Non-systematic Assessment | Right internal jugular vein traumatic insertion and dilation |
| |
| Cardiovascular event, non-serious | Cardiac disorders | Non-systematic Assessment | Self-limited unexplained hypotension or bradycardia, not requiring treatment. |
| |
| Surgical site infection | Infections and infestations | Non-systematic Assessment | Within 2 weeks of surgery. |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael P. Bokoch, Principal Investigator | University of California, San Francisco | 415-476-8389 | Michael.Bokoch@ucsf.edu |
| Sep 20, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D058625 | End Stage Liver Disease |
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| D006526 | Hepatitis C |
| D006509 | Hepatitis B |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008104 | Liver Cirrhosis, Alcoholic |
| D006528 | Carcinoma, Hepatocellular |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hepatitis B |
|
| Alcoholic |
|
| Nonalcoholic steatohepatitis (NASH) |
|
| Cryptogenic |
|
| Other |
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|
| OG001 | Normothermia & Esophageal Cooling/Warming Device | The target core temperature is 36.5-37.5 °C. Esophageal cooling/warming device: The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C. Normothermia: After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation. |
|
|