Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
VitaminC
Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
October 19, 2020
CompletedOctober 19, 2020
September 1, 2020
5.5 years
February 5, 2010
January 4, 2017
September 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)
30 days
Secondary Outcomes (1)
Renal Insufficiency
hospital discharge
Study Arms (2)
A-Ascorbic Acid (Vitamin C)
ACTIVE COMPARATORAscorbic 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.
B-5% Dextrose Water or Normal Saline
PLACEBO COMPARATOR5% 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.
Interventions
Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Eligibility Criteria
You may qualify if:
- Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.
You may not qualify if:
- History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Spotnitz, MD
- Organization
- Rutgers RWJMS
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Spotnitz
Rutgers RWJMS
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2010
First Posted
July 22, 2010
Study Start
October 1, 2007
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
October 19, 2020
Results First Posted
October 19, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share