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

Primary Purpose

Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ascorbic Acid
5 % Dextrose Water or Normal Saline
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reperfusion Injury focused on measuring Free Radicals, Ascorbic Acid, Cardiac Surgery, Prevention of Reperfusion Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Robert Wood Johnson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A-Ascorbic Acid (Vitamin C)

B-5% Dextrose Water or Normal Saline

Arm Description

Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.

5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.

Outcomes

Primary Outcome Measures

Mortality
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)

Secondary Outcome Measures

Renal Insufficiency
The number of patients who develop renal insufficiency during hospitalization.

Full Information

First Posted
February 5, 2010
Last Updated
September 24, 2020
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01167569
Brief Title
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Acronym
VitaminC
Official Title
Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury
Keywords
Free Radicals, Ascorbic Acid, Cardiac Surgery, Prevention of Reperfusion Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-Ascorbic Acid (Vitamin C)
Arm Type
Active Comparator
Arm Description
Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours.
Arm Title
B-5% Dextrose Water or Normal Saline
Arm Type
Placebo Comparator
Arm Description
5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid
Other Intervention Name(s)
Vitamin C
Intervention Description
Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
Intervention Type
Other
Intervention Name(s)
5 % Dextrose Water or Normal Saline
Other Intervention Name(s)
D5W or NS
Intervention Description
100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Primary Outcome Measure Information:
Title
Mortality
Description
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Renal Insufficiency
Description
The number of patients who develop renal insufficiency during hospitalization.
Time Frame
hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Spotnitz
Organizational Affiliation
Rutgers RWJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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