Status:
SUSPENDED
Parenteral Ascorbic Acid Repletion in TransplantatIon
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Liver Transplant Failure and Rejection
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 t...
Detailed Description
HYPOTHESIS: Administration of supraphysiologic doses of parenteral AA in the perioperative period for patients undergoing liver transplantation will improve Sequential Organ Failure Assessment (SOFA) ...
Eligibility Criteria
Inclusion
- The subject is scheduled to undergo primary deceased donor solidary liver transplantation
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04756063
Start Date
January 1 2026
End Date
January 1 2032
Last Update
October 16 2025
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792