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This study is being conducted to assess the safety of Direct Peritoneal Resuscitation (DPR) in high-risk liver transplant patients. The investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreciated in other surgical patients. The combination of elevated BMI and impaired kidney function increases the risk of 1) needing intensive care unit (ICU) admission after surgery, 2) slow function of the new liver [technically termed Early Allograft Dysfunction (EAD)] and 3) need for more than one operation. The study team also aims to identify if DPR can reduce these risks and not cause other unexpected complications following surgery. DPR involves the infusion of a solution into the abdomen and has been shown to reduce edema and improve blood flow in organs. The solution used in this study is a commercially available peritoneal dialysate, a dextrose containing solution that is infused into the abdominal cavity and is routinely used in patients with end-stage renal disease requiring dialysis.
The central hypothesis of this study is that direct peritoneal resuscitation is a safe therapy following liver transplantation and is associated with a reduced rate of return to the operating room.
AIM 1: Determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and ICU admission. Hypothesis: Liver transplant recipients that receive DPR will have comparable complication rates to historic controls of liver transplant recipients with similar demographics.
AIM 2: Identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. Hypothesis: DPR will demonstrate a trend of a reduce rate of return to the operating room of liver transplant patients after index operation compared to historic controls.
AIM 3: Identify if direct peritoneal resuscitation reduces the rate of early allograft dysfunction and other organ failure following liver transplantation with interval improvement in post-operative fibrinolysis activity. Hypothesis: DPR will reduce the rate of EAD of liver transplant patients compared to historic controls and is associated with increased fibrinolysis in the post-operative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Peritoneal Resuscitation (DPR) Group | Experimental | At the time of abdominal closure and determination that the patient will either go to extended stay or the intensive care unit, three drains will be placed per standard of care. An additional 19 French drain will be placed at the ligament of Treitz at the base of the mesentery. Following abdominal closure DPR will be initiated with commercially available 2.5% glucose-based peritoneal dialysis solution at a rate of 1.5 cc/kg/hr based on previously reported therapy in trauma. Drains will be connected to continuous wall suction. This infusion will continue for the duration the patients stay in extended stay (8 hours) if they are deemed eligible for hospital ward admission, or for 24 hours if requiring ICU care. These patients will then be observed for their hospital course and monitored for outcomes listed above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct Peritoneal Resuscitation | Procedure | Direct peritoneal resuscitation involves the abdominal infusion and drainage of a peritoneal dialysate in high-risk liver transplant patients, for up to 24 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients that complete DPR infusion without reaching stopping criteria | Up to 24 hours after initiation of direct peritoneal resuscitation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of return to the operating room after index operation | Amount of patients that require a re-operation after their transplant | Up to 7 days after transplant |
| Abdominal compartment syndrome requiring reoperation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hunter B Moore, M.D., P.hD. | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHealth - Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26384838 | Background | Weaver JL, Smith JW. Direct Peritoneal Resuscitation: A review. Int J Surg. 2016 Sep;33(Pt B):237-241. doi: 10.1016/j.ijsu.2015.09.037. Epub 2015 Sep 16. | |
| 20421025 | Background | Smith JW, Garrison RN, Matheson PJ, Franklin GA, Harbrecht BG, Richardson JD. Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery. J Am Coll Surg. 2010 May;210(5):658-64, 664-7. doi: 10.1016/j.jamcollsurg.2010.01.014. |
| Label | URL |
|---|---|
| Direct Peritoneal Resuscitation: A review. | View source |
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| 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 | Nov 1, 2021 | Dec 12, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2021 | Dec 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| D009765 | Obesity |
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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All study subjects will be enrolled to the treatment arm
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Number of patients that develop increased intraabdominal pressure as a consequence of dialysate infusion
| Events that occur during the duration of the DPR infusion, which will last no more than 24 hours after the participant's transplant surgery. |
| Percent of patients that complete DPR infusion | Up to 24 hours after initiation of DPR |
| Percent of patients that are transferred to hospital ward | Patients that are admitted to the hospital ward after surgery, not requiring ICU admission | Up to 24 hours after surgery |
| Rate of early allograft dysfunction | Patients who experience slow function of their transplanted liver after their transplant | Up to 7 days after transplant |
| Number of blood product units required during first 24 hours postoperatively | The study team will record the number of units of blood product (i.e. "bags" of red blood cells, platelets, etc.) required by the participant in the first day after liver transplantation. | Up to 24 hours after transplant |
| Number of participants that require renal replacement therapy (i.e. hemodialysis) during the first 7 days after liver transplant. | Researches will record whether the participant developed renal failure requiring renal replacement therapy (i.e. hemodialysis) | Up to 7 days after transplant |
| Hourly urine output for first 24 hours | Up to 24 hours after transplant |
| Rate of early infection after transplant | Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia. | <7 days postoperatively |
| Rate of late infection after transplant | Researchers will record any infections that participants develop after transplantation. These may include abscess, peritonitis, bacteremia, and pneumonia. | 7-30 days postoperatively |
| Rate of mechanical bowel obstruction | Constipation caused by compression from inside or outside of the bowel lumen | Up to 30 days after transplant |
| Ileus/time to oral intake | Time to return of normal bowel function and food tolerance after transplant | Up to 30 days after transplant |
| Duration of insulin infusion post-operatively | Insulin requirements after transplant surgery | Up to 7 days after transplant |
| Ventilator free days | Outcome measurement that looks into rate of respiratory failure requiring prolonged mechanical ventilation after transplant surgery | Up to 28 days post-op |
| 15761343 | Background | Zakaria el R, Garrison RN, Kawabe T, Harris PD. Direct peritoneal resuscitation from hemorrhagic shock: effect of time delay in therapy initiation. J Trauma. 2005 Mar;58(3):499-506; discussion 506-8. doi: 10.1097/01.ta.0000152892.24841.54. |
| 24952444 | Background | Smith JW, Ghazi CA, Cain BC, Hurt RT, Garrison RN, Matheson PJ. Direct peritoneal resuscitation improves inflammation, liver blood flow, and pulmonary edema in a rat model of acute brain death. J Am Coll Surg. 2014 Jul;219(1):79-87. doi: 10.1016/j.jamcollsurg.2014.03.045. Epub 2014 Apr 5. |
| 27345902 | Background | Weaver JL, Matheson PJ, Hurt RT, Downard CD, McClain CJ, Garrison RN, Smith JW. Direct Peritoneal Resuscitation Alters Hepatic miRNA Expression after Hemorrhagic Shock. J Am Coll Surg. 2016 Jul;223(1):68-75. doi: 10.1016/j.jamcollsurg.2016.03.024. Epub 2016 Mar 26. |
| 25797737 | Background | Smith JW, Matheson PJ, Morgan G, Matheson A, Downard C, Franklin GA, Garrison RN. Addition of direct peritoneal lavage to human cadaver organ donor resuscitation improves organ procurement. J Am Coll Surg. 2015 Apr;220(4):539-47. doi: 10.1016/j.jamcollsurg.2014.12.056. Epub 2015 Feb 9. |
| Direct peritoneal resuscitation accelerates primary abdominal wall closure after damage control surgery. | View source |
| Direct peritoneal resuscitation from hemorrhagic shock: effect of time delay in therapy initiation. | View source |
| Direct peritoneal resuscitation improves inflammation, liver blood flow, and pulmonary edema in a rat model of acute brain death. | View source |
| Direct Peritoneal Resuscitation Alters Hepatic miRNA Expression after Hemorrhagic Shock. | View source |
| Addition of direct peritoneal lavage to human cadaver organ donor resuscitation improves organ procurement. | View source |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |