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NCT02762331 · ClinicalTrials.gov registry record · Phase 1
High Dose Vitamin C in Cardiac Surgery Patients
A Phase 1 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02762331 is a Phase 1 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 6 participants.
The verdict
NCT02762331, a Phase 1 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third post-operative day. Reduction of AF by various drugs is moderately effective, but involves either rate control with beta blockers or rate conversion with amiodarone after the myocardial damage processes initiating AF have already occurred. Decreasing the incidence of post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be more fruitfully approached by targeting the upstream combined processes of inflammation and coagulation activation induced by the surgical insult and associated ischemia-reperfusion (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be prevented and/or inhibited by antioxidant supplementation. Specifically the investigators hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and therefore damp down upstream inflammatory processes, leading to a reduction of downstream adverse events with demonstrable links to inflammation processes, such as AF.
Interventions
- DRUG Placebo
- DRUG Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2017-01-01 |
| Est. Completion | 2018-03-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02762331
The ClinicalTrials.gov registry entry for NCT02762331 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02762331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02762331 about?
NCT02762331 is a clinical study titled "High Dose Vitamin C in Cardiac Surgery Patients". Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third post-operative day. Reduction...
What is the current status of trial NCT02762331?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2017-01-01. Estimated completion is 2018-03-13.
What interventions are being tested in trial NCT02762331?
The interventions under investigation include: Placebo (DRUG), Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT02762331?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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