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

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ClinicalTrials.gov Identifier: NCT00519337
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : January 5, 2012
Sponsor:
Collaborator:
The Gustavus and Louise Pfeiffer Research Foundation
Information provided by (Responsible Party):
Hartford Hospital

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

Condition or disease Intervention/treatment Phase
Cardiac Surgery Inflammation Drug: Ascorbic acid Drug: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : October 2008
Primary Completion Date : October 2009
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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

Inclusion Criteria:

  • Cardiothoracic surgery

Exclusion Criteria:

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519337


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

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00519337     History of Changes
Other Study ID Numbers: WHIT002743HE
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Hartford Hospital:
Atrial Fibrillation
cardiac surgery
ascorbic acid
vitamin-c
inflammation

Additional relevant MeSH terms:
Inflammation
Atrial Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents