High-dose vitamin C for liver transplant patients
Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI): A Randomized, Double-Blinded, Placebo-Controlled Trial
This study is testing if high doses of vitamin C can help liver transplant patients recover better and have fewer complications after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT04756063 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of high doses of intravenous ascorbic acid (vitamin C) on patients undergoing liver transplantation. It is a randomized, double-blinded, placebo-controlled study where participants will receive either the vitamin C treatment or a saline placebo for 48 hours post-surgery. The primary outcome measured will be changes in the Sequential Organ Failure Assessment (SOFA) score, along with secondary outcomes including vasopressor usage and mortality rates. The study aims to determine if vitamin C can improve organ function and reduce complications following liver transplantation.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for primary deceased donor solitary liver transplantation.
Not a fit: Patients with certain conditions such as G6PD deficiency, sickle cell anemia, or those currently enrolled in another research study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could enhance recovery and reduce complications for liver transplant patients.
How similar studies have performed: While the use of vitamin C in other contexts has shown promise, this specific approach in liver transplantation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Molly Groose, MD, MS — University of Wisconsin, Madison
- Study coordinator: Helen Akere
- Email: akere@wisc.edu
- Phone: (608) 265-3243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.