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Completed

NCT Number: NCT00519337

Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

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

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Key information

Conditions

Cardiac Surgery Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hartford Hosptial

Hartford, Connecticut, 06102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cardiothoracic surgery

Exclusion criteria

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi

Treatment and study plan

ascorbic acid

Drug

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

Placebo

Drug

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

Other names: Identical Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • Gustavus and Louise Pfeiffer Research Foundation

Registry information

Official study title

The Impact of Ascorbic Acid Therapy on Inflammatory Mediators in Cardiothoracic Surgery Patients: The Atrial Fibrillation Suppression Trial IV (AFIST IV) Pilot Study

Acronym: AFIST

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Aug 22, 2007
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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