Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients (Vit C)
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|ClinicalTrials.gov Identifier: NCT01167569|
Recruitment Status : Completed
First Posted : July 22, 2010
Last Update Posted : May 22, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Reperfusion Injury||Drug: Ascorbic Acid Other: 5 % Dextrose Water or Normal Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01167569
|United States, New Jersey|
|Robert Wood Johnson University Hospital|
|New Brunswick, New Jersey, United States, 08901|