A Phase 4 interventional study of Ascorbic acid and Placebo in Cardiac Surgery and Inflammation, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-05.
Sponsored by Hartford Hospital · Phase 4, Interventional, and Prevention
The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.
Atrial Fibrillation is a significant cause of morbidity following cardiothoracic surgery. Despite prophylactic therapy with beta-blockers and amiodarone, post-operative atrial fibrillation occurs in approximately 22% of patients. We believe that by reducing the inflammation that is caused during CTS, we can see further improvements without any negative effects on hemodynamics. Ascorbic acid, a free radical scavenger has been found to lower inflammation mediators but never in a CTS population. This study will help determine the affect of ascorbic acid on the inflammation associated with CTS.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Ascorbic acid
Drug: Ascorbic acid
Identical placebo
Drug: Placebo
Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days
Also known as: Vitamin-C
Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days
Also known as: Identical Placebo
In CTS patients receiving standard of care therapy,evaluate the effect of ascorbic acid therapy on c-reactive protein (CRP) concentration on post-CTS day 3 and the total post-CTS systemic exposure to CRP over 4 days.
Time frame: 4 Postoperative Days
Evaluate the effect of high intensity versus low intensity statin therapy on blood concentrations of fibrinogen, and White blood cell count on post-CTS days 3 and the total post-CTS systemic exposure to these biomarkers over 4 days.
Time frame: 4 Postoperative Days
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Hartford Hospital