Trial | NCT00519337  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin c ...

  • Study Participants

    25
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.
Study Started
Oct 31
2008
Primary Completion
Oct 31
2009
Study Completion
Apr 30
2011
Last Update
Jan 05
2012
Estimate

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 names: Vitamin-C

Drug Placebo

Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days

  • Other names: Identical Placebo

1 Active Comparator

Ascorbic acid

2 Placebo Comparator

Identical placebo

Criteria 

Inclusion Criteria:

Cardiothoracic surgery

Exclusion Criteria:

Pregnancy
Prior hypersensitivity to ascorbic acid
Renal Calculi
No Results Posted