Parenteral Ascorbic Acid Repletion in TransplantatIon

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation. Participants randomized to the intervention group will receive intravenous (IV) AA 1500 mg every 6 hours for 48 hours. Participants randomized to the control group will receive a saline placebo. The primary study outcome will be a change in the Sequential Organ Failure Assessment (SOFA) score from baseline to three days after the first dose of drug (dSOFA3). Secondary outcomes will include total vasopressor dose in norepinephrine equivalents, 30-day and 1-year mortality, and serum AA levels.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Ascorbic Acid

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