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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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