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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Ascorbic Acid
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on November 23, 2014