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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium nitrate | Experimental | Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery |
|
| Placebo | Placebo Comparator | Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium nitrate | Dietary Supplement | Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Troponin T release over the perioperative 72-hour period. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eddie T Weitzberg, MD,PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | S-171 76 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34399982 | Derived | Eriksson KE, Eidhagen F, Liska J, Franco-Cereceda A, Lundberg JO, Weitzberg E. Effects of inorganic nitrate on ischaemia-reperfusion injury after coronary artery bypass surgery: a randomised controlled trial. Br J Anaesth. 2021 Oct;127(4):547-555. doi: 10.1016/j.bja.2021.06.046. Epub 2021 Aug 14. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C031618 | sodium nitrate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium chloride | Other | Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery |
|
| 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 |
| Creatinine release over the perioperative 72-hour period | 72 h |
| Cystatin C release over the perioperative 72-hour period | 72 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017670 |
| Sodium Compounds |