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

Phase 4

Completed

• Conditions: Reperfusion Injury
• Interventions: Other: 5 % Dextrose Water or Normal Saline; Drug: Ascorbic Acid

• Registration Number: NCT01167569
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-07-21
• Study First Posted: 2010-07-22
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2017-01-04
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-24
• Last Update Submitted: 2020-09-24
• Results First Posted: 2020-10-19
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-5% Dextrose Water or Normal Saline	5 % Dextrose Water or Normal Saline	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.
A-Ascorbic Acid (Vitamin C)	Ascorbic Acid	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Renal Insufficiency	hospital discharge	The number of patients who develop renal insufficiency during hospitalization.

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States