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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01167569
First Posted: July 22, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose

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 Intervention Phase
Reperfusion Injury Drug: Ascorbic Acid Other: 5 % Dextrose Water or Normal Saline Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ]
    Number of patients (percentage) who expire within 30 days of their surgery (both in patients and discharged patients)


Secondary Outcome Measures:
  • 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.


Enrollment: 63
Study Start Date: October 2007
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Ascorbic Acid
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01167569     History of Changes
Other Study ID Numbers: 0220070054
First Submitted: February 5, 2010
First Posted: July 22, 2010
Last Update Posted: October 12, 2017
Last Verified: May 2014

Keywords provided by Rutgers, The State University of New Jersey:
Free Radicals
Ascorbic Acid
Cardiac Surgery
Prevention of Reperfusion Injury

Additional relevant MeSH terms:
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents