drugset / Trial / NCT04756063

Parenteral Ascorbic Acid Repletion in TransplantatIon

NCT04756063

Phase 4 Suspended 90 enrolled University of Wisconsin, Madison
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2026-09
Primary completion
2031-03
Completion
2032-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 1500 mg Intravenous

Indications