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Suspended NCT04756063

Parenteral Ascorbic Acid Repletion in TransplantatIon

Conditions: Liver Transplant Failure and Rejection

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 90
Sponsor: University of Wisconsin, Madison

Location: University of Wisconsin Hospital and Clinics Madison Wisconsin

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.

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04756063). StuddyBuddy aggregates publicly available trial information.