search
Back to results

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

Primary Purpose

Cardiac Surgery, Inflammation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ascorbic acid
Placebo
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Surgery focused on measuring Atrial Fibrillation, cardiac surgery, ascorbic acid, vitamin-c, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cardiothoracic surgery

Exclusion Criteria:

  • Pregnancy
  • Prior hypersensitivity to ascorbic acid
  • Renal Calculi

Sites / Locations

  • Hartford Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Ascorbic acid

Identical placebo

Outcomes

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.

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.

Full Information

First Posted
August 20, 2007
Last Updated
January 3, 2012
Sponsor
Hartford Hospital
Collaborators
The Gustavus and Louise Pfeiffer Research Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00519337
Brief Title
Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
Acronym
AFIST
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
The Gustavus and Louise Pfeiffer Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Inflammation
Keywords
Atrial Fibrillation, cardiac surgery, ascorbic acid, vitamin-c, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Ascorbic acid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Identical placebo
Intervention Type
Drug
Intervention Name(s)
Ascorbic acid
Other Intervention Name(s)
Vitamin-C
Intervention Description
Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Identical Placebo
Intervention Description
Placebo capsule, 4 capsules the night before surgery followed by 1 capsule B.I.D. for 4 postoperative days
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiothoracic surgery Exclusion Criteria: Pregnancy Prior hypersensitivity to ascorbic acid Renal Calculi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Michael White, Pharm.D.
Organizational Affiliation
Hartford Hospital, University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hosptial
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

We'll reach out to this number within 24 hrs