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

August 20, 2007
January 3, 2012
October 2008
October 2009   (final data collection date for primary outcome measure)
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 ]
In CTS patients receiving standard of care therapy,evaluate the effect of high intensity versus low intensity statin 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 ]
Complete list of historical versions of study NCT00519337 on ClinicalTrials.gov Archive Site
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 ]
Evaluate the effect of high intensity versus low intensity statin therapy on blood concentrations of interleukin-6, 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 ]
Not Provided
Not Provided
 
Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
The Impact of Ascorbic Acid Therapy on Inflammatory Mediators in Cardiothoracic Surgery Patients: The Atrial Fibrillation Suppression Trial IV (AFIST IV) Pilot Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiac Surgery
  • Inflammation
  • 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
  • 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
  • Active Comparator: 1
    Ascorbic acid
    Intervention: Drug: Ascorbic acid
  • Placebo Comparator: 2
    Identical placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2011
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Cardiothoracic surgery

Exclusion Criteria:

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519337
WHIT002743HE
Yes
Hartford Hospital
Hartford Hospital
The Gustavus and Louise Pfeiffer Research Foundation
Principal Investigator: C. Michael White, Pharm.D. Hartford Hospital, University of Connecticut
Hartford Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP