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Completed

NCT Number: NCT01348971

Coronary Artery Bypass and Nitrate Oral Supplementation

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital

Stockholm, S-171 76, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Sodium nitrate

Dietary Supplement

Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery

Sodium Chloride

Other

Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery

Primary outcomes

  1. Troponin T release over the perioperative 72-hour period.

    Time frame: 72 hours

Secondary outcomes

  1. Troponin T release over the perioperative 24-hour period.

    Time frame: 24 h

  2. Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period

    Time frame: 72 hours

  3. Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period

    Time frame: 24 hours

  4. Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.

    Time frame: 72 hours

  5. Aspartate aminotransferase (AST) release over the perioperative 72-hour period.

    Time frame: 72 hours

  6. Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.

    Time frame: 72 hours

  7. Alkaline phosphatase (ALP) release over the perioperative 72-hour period.

    Time frame: 72 hours

  8. Bilirubin release over the perioperative 72-hour period

    Time frame: 72 hours

  9. Creatinine release over the perioperative 72-hour period

    Time frame: 72 h

  10. Cystatin C release over the perioperative 72-hour period

    Time frame: 72

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Effects of Oral Nitrate During Coronary Artery Bypass Surgery

Acronym: CABANOS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 6, 2011
Registry last updated
Sep 26, 2013

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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