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
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