Coronary Artery Bypass and Nitrate Oral Supplementation (CABANOS)

September 24, 2013 updated by: Eddie Weitzberg, Karolinska Institutet

Effects of Oral Nitrate During Coronary Artery Bypass Surgery

The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.

During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-171 76
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing coronary artery bypass surgery
  • Over 18 years of age

Exclusion Criteria:

  • Over 80 years of age
  • Pregnancy
  • Reoperation
  • Intended heart valve or additional surgery
  • Angina or troponin release above 45 nmol/L < 48 hours before surgery
  • Medication with organic nitrates/nitrites < 24 hours before surgery
  • Medication with glibenclamide or corticosteroids
  • Significant renal, pulmonary or hepatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Dietary supplement: Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Placebo Comparator: Placebo
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Other: Sodium chloride
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Troponin T release over the perioperative 72-hour period.
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Troponin T release over the perioperative 24-hour period.
Time Frame: 24 h
24 h
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period
Time Frame: 72 hours
72 hours
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period
Time Frame: 24 hours
24 hours
Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.
Time Frame: 72 hours
72 hours
Aspartate aminotransferase (AST) release over the perioperative 72-hour period.
Time Frame: 72 hours
72 hours
Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.
Time Frame: 72 hours
72 hours
Alkaline phosphatase (ALP) release over the perioperative 72-hour period.
Time Frame: 72 hours
72 hours
Bilirubin release over the perioperative 72-hour period
Time Frame: 72 hours
72 hours
Creatinine release over the perioperative 72-hour period
Time Frame: 72 h
72 h
Cystatin C release over the perioperative 72-hour period
Time Frame: 72
72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Eddie T Weitzberg, MD,PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (Estimate)

May 6, 2011

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe