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

Hartford Hospital

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Inflammation

Treatments: Drug: Placebo; Drug: Ascorbic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00519337

WHIT002743HE

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiothoracic surgery

Exclusion criteria

• Pregnancy
• Prior hypersensitivity to ascorbic acid
• Renal Calculi

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Ascorbic acid

Treatment:

Drug: Ascorbic acid

2

Placebo Comparator group

Description:

Identical placebo

Treatment:

Drug: Placebo