Vitamin C in Cardiac Surgery Patients
Completed · Phase 1
Conditions studied: Coronary Artery Bypass Graft Surgery
In brief
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.
Key facts
- Study ID
- NCT03123107
- Run by
- Geisinger Clinic
- People needed
- 6
- Starts
- 2017-07-06
- Expected to finish
- 2019-05-31
- Last updated by the study team
- 2021-06-16
Who can join
Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients 21 to 79 years of age admitted to Geisinger Wyoming Valley (GWV) and scheduled to undergo urgent CABG
- Planned utilization of cardiopulmonary bypass during the surgical procedure
You may not qualify if…
- Body mass index greater than 30 kg/m2
- Estimated creatinine clearance less than 30 ml/min
- History of persistent or permanent atrial fibrillation
- Condition associated with oxidative stress or inflammation (e.g. chronic rheumatic, inflammatory or neoplastic disease, recent infection, etc.)
- Currently taking corticosteroids, non-steroidal anti-inflammatory drugs or deferoxamine
- History of oxalate kidney stones
- Currently pregnant
- History of allergic reaction to ascorbic acid products
- Currently taking any herbals or supplements (not including a multivitamin or calcium)
- Enrolled in another research study
Where it is running
- Geisinger Wyoming Valley Medical Center — Wilkes-Barre, Pennsylvania, United States
Full record on ClinicalTrials.gov
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