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NCT Number: NCT04756063

Parenteral Ascorbic Acid Repletion in TransplantatIon

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.

Why the study stopped: Staffing patterns
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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

HYPOTHESIS: Administration of supraphysiologic doses of parenteral AA in the perioperative period for patients undergoing liver transplantation will improve Sequential Organ Failure Assessment (SOFA) scores, vasopressor usage and biochemical, cellular and clinical end-organ damage.

Specific Aim: Determine the clinical response to parenteral AA supplementation in patients undergoing liver transplantation by a randomized, double-blinded, placebo-controlled clinical trial.

Study Design: This study is a prospective, single-center, randomized trial in which 90 participants will be enrolled at the University of Wisconsin Hospitals and Clinics (UWHC). Participants must meet study eligibility criteria and be scheduled to undergo primary deceased donor solitary liver transplantation. Participants will be randomized to receive 8 doses of 1500 mg AA IV or volume-equivalent placebo every 6 hours for 48 hours, in addition to standard medical management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ascorbic acid

Drug

Intravenous vitamin C

Other names: vitamin C, ASCOR

Placebo

Other

Normal Saline

Primary outcomes

  1. Change in Sequential Organ Failure Assessment (SOFA) Score

    Time frame: baseline to 3 days after first dose

    SOFA scores are a widely used composite measure of multiorgan dysfunction, validated as an accurate predictor of short- and long-term mortality in the general ICU and liver transplant populations. Change in SOFA from baseline (delta SOFA or dSOFA) has been shown to be more predictive of mortality than other derivatives such as absolute interval SOFA scores and has been recommended as the preferred endpoint in critical care settings

    The total possible range of scores is 0-24, higher scores are indicative of a higher degree of dysfunction.

Secondary outcomes

  1. Serum AA Levels

    Time frame: Pre-treatment (baseline) and Post-treatment (up to 1 week)

  2. Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram

    Time frame: from start of anesthesia (day 1) to end of ICU stay (up to 1 week)

  3. Incidence of Early Graft Dysfunction

    Time frame: postoperative (up to 7 days or until discharge, whichever came first)

    As defined per Olthoff as: total bilirubin ≥10 or INR≥1.6 on day 7, or transaminase >2000 within first 7 days

  4. Postoperative Day 7 SOFA Score

    Time frame: postoperative (up to 3 days)

    Total range of scores 0-24 where higher scores indicate higher dysfunction.

  5. Days on Ventilator

    Time frame: postoperative (up to ~ 7 days)

  6. Incidence of Infection

    Time frame: postoperative (up to ~ 7 days)

    Surgical site, bloodstream & intra-abdominal infection rates

  7. Length of ICU stay

    Time frame: postoperative (up to ~ 7 days)

  8. Length of Hospital stay

    Time frame: postoperative (up to ~ 30 days)

  9. 30 day Mortality

    Time frame: up to 30 days post-op

  10. 1-year Mortality

    Time frame: up to 1-year post-op

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI): A Randomized, Double-Blinded, Placebo-Controlled Trial

Acronym: PARTI

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Feb 16, 2021
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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