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Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

Information source: Hartford Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiac Surgery; Inflammation

Intervention: Ascorbic acid (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hartford Hospital

Official(s) and/or principal investigator(s):
C. Michael White, Pharm.D., Principal Investigator, Affiliation: Hartford Hospital, University of Connecticut

Overall contact:
C. Michael White, Pharm.D., Phone: 860-545-2469, Email: cmwhite@harthosp.org

Summary

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

Clinical Details

Official title: The Impact of Ascorbic Acid Therapy on Inflammatory Mediators in Cardiothoracic Surgery Patients: The Atrial Fibrillation Suppression Trial IV (AFIST IV) Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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.

Secondary outcome: 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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cardiothoracic surgery

Exclusion Criteria:

- Pregnancy

- Prior hypersensitivity to ascorbic acid

- Renal Calculi

Locations and Contacts

C. Michael White, Pharm.D., Phone: 860-545-2469, Email: cmwhite@harthosp.org

Hartford Hosptial, Hartford, Connecticut 06102, United States; Recruiting
Kurt Reinhart, PharmD, Phone: 860-545-2436, Email: kreinhart@harthosp.org
C. Michael White, PharmD, Principal Investigator
Kurt M Reinhart, PharmD, Sub-Investigator
Craig I Coleman, PharmD, Sub-Investigator
William Baker, PharmD, Sub-Investigator
Jeffrey Kluger, MD, Sub-Investigator
Olivia Phung, PharmD, Sub-Investigator
Ripple Talati, PharmD, Sub-Investigator
Additional Information

Starting date: October 2008
Last updated: November 17, 2008

Page last updated: December 08, 2011

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