WithdrawnPhase 2

Perioperative Vitamin C Lung Transplant

Stopped: Decided not to proceed with study

0Started 2023-04

Plain-language summary

This study is being done to determine if parenterally administered ascorbic acid (Vitamin C) given at the time of lung transplant is safe. Vitamin C may be an effective intervention towards primary graft dysfunction (PGD). The study will enroll 69 participants who consent to the intervention. Participants who do not consent to the intervention will be treated according to standard-of-care, but may choose to be consented to have their data retrospectively reviewed. Based on our consent rate, this group may include 40-70 participants. Participants will be on study for up to 12 months.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant is scheduled for lung transplantation Exclusion Criteria: * Non-English speaking * Subject is known or believed to be pregnant * Subject is a prisoner. * Subject has impaired decision-making capacity. * Subject has known allergy to vitamin C. * Subject has history of nephrolithiasis, oxalosis or hyperoxaluria. (Cystic Fibrosis patients are at risk of occult oxalosis / hyperoxaluria, therefore they will also be excluded from the study.) * Glucose-6-phosphate dehydrogenase (G6PD) deficiency * Sickle cell anemia * Heredity hemochromatosis * Baseline creatinine \>2 mg/dL or any current kidney injury * Weight \<60 kg * Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation * Current enrolment in another research study * Not suitable for study participation due to other reasons at the discretion of the investigators.

What they're measuring

Incidence and Severity of Kidney Injury Post Operative Day (POD) 1

Timeframe: Post Operative Day 1

Incidence and Severity of Kidney Injury POD 2

Timeframe: Post Operative Day 2

Incidence and Severity of Kidney Injury POD 3

Timeframe: Post Operative Day 3

Incidence and Severity of Kidney Injury POD 4

Timeframe: Post Operative Day 4

Incidence and Severity of Kidney Injury POD 7

Timeframe: Post Operative Day 7

Incidence of New Dialysis Initiation

Timeframe: up to Post Operative Day 7

Trial details

NCT IDNCT04505878

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

View on ClinicalTrials.gov More Primary Graft Dysfunction trials