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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients

Conditions
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Reperfusion Injury

Intervention / Treatment
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* Drug: Ascorbic Acid
* Other: 5 % Dextrose Water or Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A-Ascorbic Acid (Vitamin C)<br>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. | Drug: Ascorbic Acid<br>* Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.<br>* Other names: Vitamin C;|
| Placebo Comparator: B-5% Dextrose Water or Normal Saline<br>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. | Other: 5 % Dextrose Water or Normal Saline<br>* 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.<br>* Other names: D5W or NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of patients who expire within 30 days of their surgery (both in patients and discharged patients) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Insufficiency | The number of patients who develop renal insufficiency during hospitalization. | hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Free Radicals, Ascorbic Acid, Cardiac Surgery, Prevention of Reperfusion Injury