RECRUITING

Parenteral Ascorbic Acid Repletion in TransplantatIon

Talk to us

Conditions

Liver Transplant Failure and Rejection

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04756063

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The subject is scheduled to undergo primary deceased donor solidary liver transplantation
  1. * Non-English speaking
  2. * Known or believed to be pregnant
  3. * Subject is a prisoner
  4. * Impaired decision-making capacity (i.e., current encephalopathy)
  5. * Known allergy to AA
  6. * Concurrent organ transplantation (i.e., simultaneous liver-kidney transplantation)
  7. * Planned veno-venous bypass use in the operating room
  8. * Prior parenteral or oral AA repletion
  9. * History of nephrolithiasis or oxaluria
  10. * Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
  11. * Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  12. * Sickle cell anemia
  13. * Hereditary hemochromatosis
  14. * Preoperative anuria or creatinine \>2.5mg/dL in patient not on renal replacement therapy
  15. * Current enrollment in another research study

Contacts and Locations

Study Contact

Helen Akere
CONTACT
(608) 265-3243
akere@wisc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2030-12

Study Record Updates

Study Start Date2024-12
Study Completion Date2030-12

Terms related to this study

Additional Relevant MeSH Terms

  • Liver Transplant Failure and Rejection