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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 20, 2007

Last Updated Date

January 3, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00519337 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cardiac Surgery
Inflammation

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1
Ascorbic acid

Intervention: Drug: Ascorbic acid
Placebo Comparator: 2
Identical placebo

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cardiothoracic surgery

Exclusion Criteria:

Pregnancy
Prior hypersensitivity to ascorbic acid
Renal Calculi

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00519337

Other Study ID Numbers ^ICMJE

WHIT002743HE

Has Data Monitoring Committee

Yes

Responsible Party

Hartford Hospital

Study Sponsor ^ICMJE

Hartford Hospital

Collaborators ^ICMJE

The Gustavus and Louise Pfeiffer Research Foundation

Investigators ^ICMJE

Principal Investigator:

C. Michael White, Pharm.D.

Hartford Hospital, University of Connecticut

Information Provided By

Hartford Hospital

Verification Date

January 2012

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

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