Clinical trial

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

Name
EC 20/606
Description
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.
Trial arms
Trial start
2020-11-17
Estimated PCD
2023-06-30
Trial end
2023-07-30
Status
Recruiting
Phase
Early phase I
Treatment
Ascorbic acid
1.5 gr of ascorbic acid
Arms:
Ascorbic acid
Other names:
Vitamin C
0.9% Saline solution
100 ml of 0.9% saline solution
Arms:
Saline solution
Other names:
Saline
Size
70
Primary endpoint
Postreperfusion syndrome
Within the first 5 minutes after reperfusion of the grafted liver
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}
Updated at
2023-03-03

1 organization

2 products

3 indications

Indication
Vitamin C