Parenteral Ascorbic Acid Repletion in TransplantatIon

Launched by UNIVERSITY OF WISCONSIN, MADISON · Feb 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of high doses of vitamin C, also known as ascorbic acid, in patients who are about to undergo a liver transplant. Researchers want to see if giving vitamin C through an IV can help improve the function of the liver after the transplant and reduce complications. Participants will be randomly assigned to either receive the vitamin C treatment or a saline solution that looks like the vitamin C but doesn't have any active ingredients (this is called a placebo). The main goal is to see how well their organs are functioning three days after treatment, but the study will also look at other factors like how many medicines they need to support their blood pressure and their survival rates over the next month and year.

To be eligible for this trial, participants must be scheduled for a liver transplant from a deceased donor and be between 18 and 80 years old. However, certain individuals won't be able to participate, such as those who are pregnant, have specific medical conditions, or are currently in other research studies. If someone joins, they can expect to receive treatment for 48 hours, where they'll either get vitamin C or the placebo, and then their health will be monitored closely. This trial is currently recruiting participants, and everyone involved will help researchers understand if vitamin C can play a role in improving liver transplant outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subject is scheduled to undergo primary deceased donor solidary liver transplantation
• Exclusion Criteria:
• • Non-English speaking
• • Known or believed to be pregnant
• • Subject is a prisoner
• • Impaired decision-making capacity (i.e., current encephalopathy)
• • Known allergy to AA
• • Concurrent organ transplantation (i.e., simultaneous liver-kidney transplantation)
• • Planned veno-venous bypass use in the operating room
• • Prior parenteral or oral AA repletion
• • History of nephrolithiasis or oxaluria
• • Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
• • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• • Sickle cell anemia
• • Hereditary hemochromatosis
• • Preoperative anuria or creatinine \>2.5mg/dL in patient not on renal replacement therapy
• • Current enrollment in another research study