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

Reperfusion Injury Clinical Trial

— VitaminC  

Official title:

Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167569
• Other study ID #: 0220070054
• Status: Completed
• Phase: Phase 4
• Start date: October 2007
• Est. completion date: April 2013

Study information

• Verified date: September 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Reperfusion Injury

Intervention

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:
• 5 % Dextrose Water or Normal Saline
100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)	30 days
Secondary	Renal Insufficiency	The number of patients who develop renal insufficiency during hospitalization.	hospital discharge