Parenteral Ascorbic Acid Repletion in TransplantatIon

NCT04756063 | Suspended Phase 4 FDA Drug

• 4 other identifiers: 2020-1153A530900SMPH/ANESTHESIOLOGYProtocol Version 12/5/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (1)

• Change in Sequential Organ Failure Assessment (SOFA) Score

  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.

  baseline to 3 days after first dose

Secondary Outcomes (10)

• Serum AA Levels

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

• Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram

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

• Incidence of Early Graft Dysfunction

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

• Postoperative Day 7 SOFA Score

  postoperative (up to 3 days)

• Days on Ventilator

  postoperative (up to ~ 7 days)

Study Arms (2)

Ascorbic Acid (AA)

EXPERIMENTAL

The first intravenous dosage of 1500mg of AA in 100mL of normal saline (NS) will be administered after induction of general anesthesia and invasive line placement prior to surgical incision. An identical dosage will be delivered approximately every 6 hours for the first 48 hours, for a total of 8 doses

Drug: Ascorbic acid

Placebo

PLACEBO COMPARATOR

The first intravenous dosage of placebo (100 mL of NS) will be administered after induction of general anesthesia and invasive line placement prior to surgical incision. An identical dosage will be delivered approximately every 6 hours for the first 48 hours, for a total of 8 doses

Other: Placebo

Interventions

Ascorbic acid DRUG

Intravenous vitamin C

Also known as: vitamin C, ASCOR

Ascorbic Acid (AA)

Placebo OTHER

Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is scheduled to undergo primary deceased donor solidary liver transplantation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Molly Groose, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: April 2, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: up to 7 years after primary completion

Locations

US (1)