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Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation (AFIST)

This study has been completed.
The Gustavus and Louise Pfeiffer Research Foundation
Information provided by (Responsible Party):
Hartford Hospital Identifier:
First received: August 20, 2007
Last updated: January 3, 2012
Last verified: January 2012
The purpose of this study is to see if ascorbic acid (Vitamin-C) therapy will reduce inflammation following heart surgery.

Condition Intervention Phase
Cardiac Surgery
Drug: Ascorbic acid
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: October 2008
Study Completion Date: April 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ascorbic acid
Drug: Ascorbic acid
Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days
Other Name: Vitamin-C
Placebo Comparator: 2
Identical placebo
Drug: Placebo
Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days
Other Name: Identical Placebo

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cardiothoracic surgery

Exclusion Criteria:

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi
  Contacts and Locations
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Please refer to this study by its identifier: NCT00519337

United States, Connecticut
Hartford Hosptial
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Hartford Hospital
The Gustavus and Louise Pfeiffer Research Foundation
Principal Investigator: C. Michael White, Pharm.D. Hartford Hospital, University of Connecticut
  More Information

Responsible Party: Hartford Hospital Identifier: NCT00519337     History of Changes
Other Study ID Numbers: WHIT002743HE
Study First Received: August 20, 2007
Last Updated: January 3, 2012

Keywords provided by Hartford Hospital:
Atrial Fibrillation
cardiac surgery
ascorbic acid

Additional relevant MeSH terms:
Atrial Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents processed this record on April 28, 2017