Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation (AFIST)
This study has been completed.
Sponsor:
Hartford Hospital
Collaborator:
The Gustavus and Louise Pfeiffer Research Foundation
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00519337
First received: August 20, 2007
Last updated: January 3, 2012
Last verified: January 2012
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Purpose
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 Inflammation |
Drug: Ascorbic acid Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cardiothoracic surgery
Exclusion Criteria:
- Pregnancy
- Prior hypersensitivity to ascorbic acid
- Renal Calculi
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Hartford Hospital |
| ClinicalTrials.gov Identifier: | NCT00519337 History of Changes |
| Other Study ID Numbers: | WHIT002743HE |
| Study First Received: | August 20, 2007 |
| Last Updated: | January 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Hartford Hospital:
|
Atrial Fibrillation cardiac surgery ascorbic acid vitamin-c inflammation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Inflammation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Ascorbic Acid Vitamins |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013