SuspendedPhase 4

Parenteral Ascorbic Acid Repletion in TransplantatIon

Stopped: Resources

United States90 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Sequential Organ Failure Assessment (SOFA) Score

Timeframe: baseline to 3 days after first dose

Trial details

NCT IDNCT04756063

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-03