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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01167569
First received: February 5, 2010
Last updated: May 20, 2014
Last verified: May 2014
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01167569     History of Changes
Other Study ID Numbers: 0220070054
Study First Received: February 5, 2010
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

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
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Ascorbic Acid
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 25, 2014