Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation

NCT ID: NCT00519337

Last Updated: 2012-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiac Surgery Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Ascorbic acid

Group Type ACTIVE_COMPARATOR

Ascorbic acid

Intervention Type DRUG

Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days

2

Identical placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Ascorbic acid

Ascorbic acid, 2 g p.o. the night before surgery followed by 500mg B.I.D. for 4 post-operative days

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Vitamin-C Identical Placebo

Eligibility Criteria

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Inclusion Criteria

* Cardiothoracic surgery

Exclusion Criteria

* Pregnancy
* Prior hypersensitivity to ascorbic acid
* Renal Calculi
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gustavus and Louise Pfeiffer Research Foundation

UNKNOWN

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C. Michael White, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital, University of Connecticut

Locations

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Hartford Hosptial

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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WHIT002743HE

Identifier Type: -

Identifier Source: org_study_id

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