Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients (VitaminC)

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 4

Conditions: Reperfusion Injury

Treatments: Other: 5 % Dextrose Water or Normal Saline; Drug: Ascorbic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01167569

0220070054

Details and patient eligibility

About

It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.

Full description

Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.

Exclusion criteria

• History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

A-Ascorbic Acid (Vitamin C)

Active Comparator group

Description:

Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.

Treatment:

Drug: Ascorbic Acid

B-5% Dextrose Water or Normal Saline

Placebo Comparator group

Description:

5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.

Treatment:

Other: 5 % Dextrose Water or Normal Saline