Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Overview
- Phase
- Phase 4
- Intervention
- Ascorbic Acid
- Conditions
- Reperfusion Injury
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
A-Ascorbic Acid (Vitamin C)
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.
Intervention: Ascorbic Acid
B-5% Dextrose Water or Normal Saline
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.
Intervention: 5 % Dextrose Water or Normal Saline
Outcomes
Primary Outcomes
Mortality
Time Frame: 30 days
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)
Secondary Outcomes
- Renal Insufficiency(hospital discharge)