Viewing Study NCT04505878



Ignite Creation Date: 2024-05-06 @ 3:02 PM
Last Modification Date: 2024-10-26 @ 1:42 PM
Study NCT ID: NCT04505878
Status: WITHDRAWN
Last Update Posted: 2023-05-01
First Post: 2020-08-05

Brief Title: Perioperative Vitamin C Lung Transplant
Sponsor: University of Wisconsin Madison
Organization: University of Wisconsin Madison

Study Overview

Official Title: Vitamin C Assessing Safety After Lung Transplant
Status: WITHDRAWN
Status Verified Date: 2023-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Decided not to proceed with study
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: PGD is a frequent and severe outcome that impacts both short- and long-term outcomes after lung transplantation Major pathophysiologic contributors include ischemia and reperfusion injury mitochondrial dysfunction and endothelial failure No directed therapy exists Vitamin C is a first-line antioxidant that also acts at the endothelium and mitochondria to decrease permeability and leak inhibit mitochondrial dysfunction and improve ischemia and reperfusion When combined with steroids part of standard care for lung transplant recipients these effects may be enhanced and synergistically inhibit instigators of patient injury A pilot trial will ensure safety of this potential intervention and guide future research into this important outcome measure It will be readily received in the literature

For the present study vitamin C will be administered parenterally at a dose of 1500 mg every 6 hours a dose that is widely accepted and used in other clinical contexts where the drug is studied such as sepsis This will predictably reconstitute levels and achieve supratherapeutic benefit towards oxidant scavenging while avoiding the potential pro-oxidant effects seen at exceedingly high doses To this end the investigators will exclude patients where the standard dosing of vitamin C will exceed 100 mgkgday excluding patients 60 kg Dosing will continue through post-operative day POD 3 to effectively assess for the impact of vitamin C on PGD

Primary Objectives

To assess whether parenterally administered ascorbic acid vitamin C is safe in the lung transplant population
To estimate adherence to ascorbic acid administration protocol in this study population and to identify obstacles to feasibility of future trials using this protocol

Secondary Objectives

To assess whether parenterally administered ascorbic acid vitamin C may decrease the rate and severity of PGD after lung transplant
To establish the incidence of vitamin C and vitamin B1 thiamine deficiencies in the lung transplant population and the responsiveness of vitamin C levels to our selected parenteral therapy
To identify interventions that will optimize the post-operative wellbeing of patients receiving lung transplants by decreasing primary graft dysfunction short and intermediate-to-long term

Stop Criteria

Anuria x 3-hours
Moderate Grade 2 AKI doubling of baseline creatinine
An acute unexplained hemoglobin drop of 2 mgdL

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
A530900 OTHER None None
SMPHANESTHESIOLOGY OTHER None None
Protocol Version 005 OTHER UW Madison None