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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
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

February 5, 2010
July 22, 2010
May 22, 2014
October 2007
April 2013   (Final data collection date for primary outcome measure)
Mortality [ Time Frame: 30 days ]
Number of patients (percentage) who expire within 30 days of their surgery (both in patients and discharged patients)
Same as current
Complete list of historical versions of study NCT01167569 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Reperfusion Injury
  • 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
  • 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
  • Active Comparator: A
    Ascorbic Acid
    Intervention: Drug: Ascorbic Acid
  • Placebo Comparator: B
    5% Dextrose Water or Normal Saline (placebo)
    Intervention: Other: 5 % Dextrose Water or Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
400
April 2013
April 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01167569
0220070054
No
Not Provided
Not Provided
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
Not Provided
Not Provided
Rutgers, The State University of New Jersey
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP