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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
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The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an alternative to pure fluid replacement solutions that are associated with problems after surgery including fluid overload and respiratory difficulties. The safety of HES 130/0.4 (Voluven) will be evaluated by examining its effects on kidney function, and coagulation parameters and platelet (part of the blood that help it clot) function.
Participants will be randomized (like flipping a coin) to receive one of two possible volume replacements during surgery, if fluid volume decreases enough to need replacement with one of the fluids. The two possible volume replacements are Voluven (a starch-containing fluid) or human albumin 5% (a protein-containing solution).
To examine kidney function, urine will be-sampled when the participant is put under general anesthesia, before surgical incision, within one hour of arrival to the ICU and 24 hours after completion of surgery. Two tubes (2 teaspoons) of blood (from an already established line) will be taken the morning of the surgery, within one hour of arrival to the ICU, 24 hours after surgery and every morning during the participants postoperative ICU stay.
Additionally, health and recovery information will be recorded from the participant's medical record. We will phone participants around 90 days and one year after surgery to ask a few questions about one's health and recovery. We will also record blood sample analysis results from follow up appointments within the first year after surgery. If this analysis is not conducted at the Cleveland Clinic, with permission, we will obtain the results from a treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HES 130/0.4 (Voluven) | Experimental | 6% HES 130/0.4 during surgery |
|
| human albumin 5% | Active Comparator | human albumin 5% during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human albumin 5% | Drug |
| ||
| HES 130/0.4 (Voluven) |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery. | 3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Function | Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis. RIFLE classification criteria is listed below: Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function > 4 weeks End stage (RIFLE-E) End-stage kidney failure > 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andra Duncan, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34406128 | Derived | Lee MJ, Tannenbaum C, Mao G, Jia Y, Leung S, Yilmaz HO, Ince I, Soltesz E, Duncan AE. Effect of 6% Hydroxyethyl Starch 130/0.4 on Inflammatory Response and Pulmonary Function in Patients Having Cardiac Surgery: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):906-914. doi: 10.1213/ANE.0000000000005664. | |
| 33744114 | Derived |
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9 more patients were recruited to ensure enough power after excluding patients who were randomized but they withdrew from the study and did not receive any treatment (see periods section for details).
9 more patients were recruited due to withdrawal (patients did not receive any treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | HES 130/0.4 (Voluven) | 6% HES 130/0.4 during surgery HES 130/0.4 (Voluven) |
| FG001 | Human Albumin 5% | human albumin 5% during surgery human albumin 5% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HES 130/0.4 (Voluven) | 6% HES 130/0.4 during surgery HES 130/0.4 (Voluven) |
| BG001 | Human Albumin 5% | human albumin 5% during surgery human albumin 5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Urine Neutrophil Gelatinase-associated Lipocalin (NGAL) [Time Frame: 24 Hours After Surgery] [Designated as Safety Issue: Yes] | To assess the safety of HES 130/0.4 (Voluven) versus albumin 5% on renal function we will measure urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL), an important marker of renal function, measured at baseline (following anesthetic induction and prior to surgical incision), at one hour of arrival to intensive care unit (ICU), at 24 hours following completion of surgery. | Posted | Median | Inter-Quartile Range | ng/ml | 3 measurements in total from baseline to 24 hours after surgery: the first one is at baseline; the second one is at one hour of arrive to ICU and last one is at 24 hours after surgery |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HES 130/0.4 (Voluven) | 6% HES 130/0.4 during surgery HES 130/0.4 (Voluven) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andra Duncan | Cleveland Clinic | 216-538-6944 | duncana@ccf.org |
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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 | Jun 19, 2018 | May 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| C485123 | HES 130-0.4 |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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|
| within first 7 postoperative days |
| Postop Urine IL-18 | Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU | postoperative 1 hour |
| Postop Urine IL-18 | Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery | 24 hours after surgery |
| Katabi LJ, Pu X, Yilmaz HO, Jia Y, Leung S, Duncan AE. Prognostic Utility of KDIGO Urine Output Criteria After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2991-3000. doi: 10.1053/j.jvca.2021.02.027. Epub 2021 Feb 13. |
| 32072617 | Derived | Duncan AE, Jia Y, Soltesz E, Leung S, Yilmaz HO, Mao G, Timur AA, Kottke-Marchant K, Rogers HJ, Ma C, Ince I, Karimi N, Yagar S, Trombetta C, Sessler DI. Effect of 6% hydroxyethyl starch 130/0.4 on kidney and haemostatic function in cardiac surgical patients: a randomised controlled trial. Anaesthesia. 2020 Sep;75(9):1180-1190. doi: 10.1111/anae.14994. Epub 2020 Feb 18. |
| did not receive intervention due to logistic reasons |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Myocardial infarction | Count of Participants | Participants |
|
| Surgery type | Count of Participants | Participants |
|
| Duration of aortic cross-clamp | Median | Inter-Quartile Range | minutes |
|
| Total fluid | total fluid is the amount of colloids and crystalloids during surgery | Median | Inter-Quartile Range | L |
|
| Transfusion | "Transfusion" Row is reporting the total number of participants who had at least one transfusion | Count of Participants | Participants |
|
| Volume of study solution | Median | Inter-Quartile Range | ml |
|
| Previous cardiac surgery | Count of Participants | Participants |
|
| Use of antifibrinolytic drug | Count of Participants | Participants |
|
| Human Albumin 5% |
human albumin 5% during surgery human albumin 5% |
|
|
|
| Secondary | Kidney Function | Postoperative kidney dysfunction using RIFLE diagnostic criteria was also assessed. Patients were assessed for risk for kidney dysfunction (RIFLE-R), injury to the kidney (RIFLE-I), failure of kidney function (RIFLE-F) using criteria based on only peak serum creatinine concentrations within the first seven postoperative days. Due to too few events, this outcome was redefined to risk (or worse) vs. no risk for this analysis. RIFLE classification criteria is listed below: Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline Loss (RIFLE-L) Complete loss of kidney function > 4 weeks End stage (RIFLE-E) End-stage kidney failure > 3 months | Posted | Count of Participants | Participants | within first 7 postoperative days |
|
|
|
|
| Secondary | Postop Urine IL-18 | Postop Urine IL-18 (interleukin-18) measured at 1 h of arrival to ICU | Posted | Median | Inter-Quartile Range | pg/ml | postoperative 1 hour |
|
|
|
|
| Secondary | Postop Urine IL-18 | Postoperative urine IL-18 (interleukin-18) measured at 24 hours after surgery | Posted | Median | Inter-Quartile Range | pg/ml | 24 hours after surgery |
|
|
|
|
| Post-Hoc | Kidney Function | kidney injury using RIFLE criteria based on both peak creatinine levels and urine output, as recommended by Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group RIFLE classification criteria is listed below: Risk (RIFLE-R) Increase in serum creatinine x 1.5 from baseline urine output < 0.5 mL/kg/hr for more than 6 hrs Injury (RIFLE-I) Increase in serum creatinine x 2 from baseline urine output < 0.5 mL/kg/hr for more than 12 hrs Failure (RIFLE-F) Increase in serum creatinine x 3 from baseline urine output < 0.3 mL/kg/hr for 24 hrs or anuria for 12 hrs Loss (RIFLE-L) Complete loss of kidney function > 4 weeks End stage (RIFLE-E) End-stage kidney failure > 3 months | Posted | Count of Participants | Participants | within the first seven postoperative days |
|
|
|
|
| 69 |
| 17 |
| 69 |
| 0 |
| 69 |
| EG001 | Human Albumin 5% | human albumin 5% during surgery human albumin 5% | 2 | 72 | 12 | 72 | 0 | 72 |
| cardiac-related | Cardiac disorders | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Nervous disorder | Nervous system disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| respiratory related event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D011134 |
| Polysaccharides |
| Injury |
|
| Failure |
|
| Injury |
|
| Failure |
|