CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Ascorbic Aciddrug
Likely dose
Ascorbic Acid 100 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03123107
NCT03123107Phase 1Completed

Advancing the Cardiovascular Science of Vitamin C in Cardiac Surgery Patients

Geisinger Clinic·interventional·Posted Apr 21, 2017·Updated Jun 16, 2021

In Brief

A Phase 1 clinical trial evaluating Ascorbic Acid for Coronary Artery Bypass Graft Surgery. Completed, enrolled 6 participants across 1 site.

Detailed Summary

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery that increases the incidence of stroke, kidney injury and death. Vitamin C has been shown to decrease the incidence of POAF follow cardiac surgery, but the optimal dose has not been identified. With this project, the investigators plan to gather pharmacokinetic and dose-response data for vitamin C in the cardiac surgery population. The investigators plan to conduct a small interventional pilot study investigating the pharmacokinetics and pharmacodynamics of Vitamin C in patients undergoing coronary artery bypass graft (CABG) surgery. Patients enrolled will receive an intravenous dose of Vitamin C the day before surgery and the day after. Patients will have blood samples obtained with each dose for analysis of vitamin C concentrations and several biomarkers of oxidative stress. Analysis of samples will be performed within the Department of Pharmaceutical Sciences at Wilkes University.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsWilkes University

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedApr 21, 2017
Enrollment StartJul 6, 2017
Primary CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.2 years ago

Interventions

Ascorbic Aciddrug

Ascorbic acid doses will be mixed in 100 mL normal saline and infused over 60 minutes. The postoperative dose will be given on postoperative day #1.