Parenteral Ascorbic Acid Repletion in TransplantatIon

Description

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

Study Overview

Study Details

Study overview

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.

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

Parenteral Ascorbic Acid Repletion in TransplantatIon

Condition
Liver Transplant Failure and Rejection
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Molly Groose, MD, MS, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2030-12