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Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

Phase 4
Completed
Conditions
Cardiac Surgery
Inflammation
Interventions
Drug: Placebo
Registration Number
NCT00519337
Lead Sponsor
Hartford Hospital
Brief Summary

The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
Inclusion Criteria
  • Cardiothoracic surgery
Exclusion Criteria
  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2PlaceboIdentical placebo
1Ascorbic acidAscorbic acid
Primary Outcome Measures
NameTimeMethod
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.4 Postoperative Days
Secondary Outcome Measures
NameTimeMethod
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.4 Postoperative Days

Trial Locations

Locations (1)

Hartford Hosptial

🇺🇸

Hartford, Connecticut, United States

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