Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation (VITACTOH)

Madrid Health Service

Status and phase: Enrolling; Phase 2

Conditions: Ascorbic Acid; Liver Transplantation; Postreperfusion Syndrome

Treatments: Drug: Ascorbic acid; Drug: 0.9% Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05754242

EC 20/606

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 67 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Ascorbic acid

Experimental group

Description:

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

Treatment:

Drug: Ascorbic acid

Saline solution

Placebo Comparator group

Description:

100 ml of 0.9% saline solution will be administered during the anhepatic phase of liver transplantation

Treatment:

Drug: 0.9% Saline solution