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

NCT ID: NCT01167569

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2013-04-30

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.

Conditions

Reperfusion Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

A-Ascorbic Acid (Vitamin C)

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.

Group Type: ACTIVE_COMPARATOR

Ascorbic Acid

Intervention Type: DRUG

Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.

B-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.

Group Type: PLACEBO_COMPARATOR

5 % Dextrose Water or Normal Saline

Intervention Type: OTHER

100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.

Interventions

Ascorbic Acid

Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.

Intervention Type: DRUG

5 % Dextrose Water or Normal Saline

100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.

Intervention Type: OTHER

Other Intervention Names

Vitamin C; D5W or NS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Spotnitz

Role: PRINCIPAL_INVESTIGATOR

Rutgers RWJMS

Locations

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

0220070054

Identifier Type: -

Identifier Source: org_study_id