Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation

Study Overview
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Brief Summary
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The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are: Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ? Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation? Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ? Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft. Researchers will compared the incidence of postreperfusion syndrome in both groups.

Detailed Description
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Researches will compared: Incidence of postreperfusion syndrome in liver transplantation Changes in interleukin values and other inflammatory markers before and after transplantation Incidence of liver graft dysfunction between groups Incidence of acute renal failure and other complications between groups

Official Title
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Intravenous Vitamin C for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation From Deceased Donors

Conditions
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Liver Transplantation, Postreperfusion Syndrome, Ascorbic Acid

Intervention / Treatment
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* Drug: Ascorbic acid
* Drug: 0.9% Saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing liver transplantation Exclusion Criteria: Pregnancy Allergy to ascorbic acid Nephrolithiasis Glucose-6-phosphate dehydrogenase (G6PD) deficiency Hyperoxaluria Hyperuricemia Haemochromatosis Sickle cell anemia Serum Creatinine > 1.2 mg/dl in women and 1.3 mg/dl in men Split liver graft Acute liver failure Living donor liver transplantation Controlled donor asystolia Treatment with: indinavir, Vitamin B12, Cyclosporine, iron, deferoxamine, disulfiram

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ascorbic acid<br>1.5 gr of ascorbic acid diluted in 100 ml of 0.9% saline solution will be administered intravenously during the anhepatic phase of liver transplantation | Drug: Ascorbic acid<br>* 1.5 gr of ascorbic acid<br>* Other names: Vitamin C;|
| Placebo Comparator: Saline solution<br>100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation | Drug: 0.9% Saline solution<br>* 100 ml of 0.9% saline solution<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postreperfusion syndrome | When mean arterial pressure decreases by more than 30% relative to the value at the end of the anhepatic phase and lasts for at least 1 min | Within the first 5 minutes after reperfusion of the grafted liver | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ascorbic acid serum levels | Quantification of ascorbic acid levels before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Interleukin1beta (IL-1β) levels | Quantification of IL-1β before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Tumor Necrosis Factor-alpha (TNFα) levels | Quantification of TNFα before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Interleukin-6 levels (IL-6) | Quantification of IL-6 before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Interleukin-8 (IL-8) levels | Quantification of IL-8 before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Interferon gamma (IFNγ) levels | Quantification of IFNγ before and after liver transplantation | Immediately before induction of anesthesia and 12 hours after repercussion of the graft | 
| Primary graft dysfunction | Incidence of primary graft nonfunction and early graft dysfunction. Graft nonfunction: lack of liver function leading to death if not retransplanted Early graft dysfunction: Olthoff's criteria | First postoperative week | 
| Acute renal failure | Postoperative renal failure after liver transplantation as Kidney Disease Improving Global Outcomes (KDIGO) definition | First postoperative week | 
| Mechanical ventilation | Duration of mechanical ventilation (hours) until extubation of the patient | Postoperative until day 30 | 
| Mortality | Mortality of any cause | Up to day 30 | 
| Length of hospitalization | Length of stay in hospital (days) | Through study completion (30 days) | 
| Length of Intensive Care Unit (ICU) stay | Length of ICU stay | Through study completion (30 days) | 
| Duration of vasopressor support after transplantation | Duration of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) | 
| Maximum dose of vasopressor support after transplantation | Maximum dose of vasopressor or inotropic support after transplantation | Postoperative until study completion (30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postreperfusion syndrome