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NCT Number: NCT01167569

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

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.

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Key information

Conditions

Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ascorbic acid

Drug

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

Other names: Vitamin C

5 % Dextrose Water or Normal Saline

Other

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

Other names: D5W or NS

Primary outcomes

  1. Mortality

    Time frame: 30 days

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

Secondary outcomes

  1. Renal Insufficiency

    Time frame: hospital discharge

    The number of patients who develop renal insufficiency during hospitalization.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Acronym: VitaminC

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2010
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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