NCT01167569

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-07-22
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

1 site across 1 country: United States