Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients (Vit C)
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.
|Reperfusion Injury||Drug: Ascorbic Acid Other: 5 % Dextrose Water or Normal Saline||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients|
- Mortality [ Time Frame: 30 days ]Number of patients (percentage) who expire within 30 days of their surgery (both in patients and discharged patients)
- Renal Insufficiency [ Time Frame: 30 Days ]The number of patients (percentage) who develop renal insufficiency within 30 days of surgery. Renal insufficiency is defined as a rise in the Creatinine from nl (<1.5 mg/dl) to 2.0 mg/dl or greater.
|Study Start Date:||October 2007|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: A
Drug: Ascorbic Acid
Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
Other Name: Vitamin C
Placebo Comparator: B
5% Dextrose Water or Normal Saline (placebo)
Other: 5 % Dextrose Water or Normal Saline
100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Other Name: D5W or NS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01167569
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08901|