Effects of Oral Nitrate During Coronary Artery Bypass Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Troponin T release over the perioperative 72-hour period.
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Intervention: Sodium chloride (Other)
Sodium nitrate
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Intervention: Sodium nitrate (Dietary Supplement)
Outcomes
Primary Outcomes
Troponin T release over the perioperative 72-hour period.
Time Frame: 72 hours
Secondary Outcomes
- Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period(24 hours)
- Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.(72 hours)
- Aspartate aminotransferase (AST) release over the perioperative 72-hour period.(72 hours)
- Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.(72 hours)
- Alkaline phosphatase (ALP) release over the perioperative 72-hour period.(72 hours)
- Bilirubin release over the perioperative 72-hour period(72 hours)
- Troponin T release over the perioperative 24-hour period.(24 h)
- Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period(72 hours)
- Creatinine release over the perioperative 72-hour period(72 h)
- Cystatin C release over the perioperative 72-hour period(72)
Investigators
Eddie Weitzberg
Professor
Karolinska Institutet