Coronary Artery Bypass and Nitrate Oral Supplementation (CABANOS)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Sodium nitrate
Sodium chloride
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease focused on measuring sodium nitrate, coronary artery bypass surgery, ischemia-reperfusion, myocardial injury
Eligibility Criteria
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
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium nitrate
Placebo
Arm Description
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Outcomes
Primary Outcome Measures
Troponin T release over the perioperative 72-hour period.
Secondary Outcome Measures
Troponin T release over the perioperative 24-hour period.
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period
Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.
Aspartate aminotransferase (AST) release over the perioperative 72-hour period.
Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.
Alkaline phosphatase (ALP) release over the perioperative 72-hour period.
Bilirubin release over the perioperative 72-hour period
Creatinine release over the perioperative 72-hour period
Cystatin C release over the perioperative 72-hour period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01348971
Brief Title
Coronary Artery Bypass and Nitrate Oral Supplementation
Acronym
CABANOS
Official Title
Effects of Oral Nitrate During Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
sodium nitrate, coronary artery bypass surgery, ischemia-reperfusion, myocardial injury
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium nitrate
Arm Type
Experimental
Arm Description
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Intervention Type
Dietary Supplement
Intervention Name(s)
Sodium nitrate
Intervention Description
Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
Intervention Type
Other
Intervention Name(s)
Sodium chloride
Intervention Description
Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
Primary Outcome Measure Information:
Title
Troponin T release over the perioperative 72-hour period.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Troponin T release over the perioperative 24-hour period.
Time Frame
24 h
Title
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period
Time Frame
72 hours
Title
Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period
Time Frame
24 hours
Title
Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.
Time Frame
72 hours
Title
Aspartate aminotransferase (AST) release over the perioperative 72-hour period.
Time Frame
72 hours
Title
Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.
Time Frame
72 hours
Title
Alkaline phosphatase (ALP) release over the perioperative 72-hour period.
Time Frame
72 hours
Title
Bilirubin release over the perioperative 72-hour period
Time Frame
72 hours
Title
Creatinine release over the perioperative 72-hour period
Time Frame
72 h
Title
Cystatin C release over the perioperative 72-hour period
Time Frame
72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie T Weitzberg, MD,PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
S-171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34399982
Citation
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.
Results Reference
derived
Learn more about this trial
Coronary Artery Bypass and Nitrate Oral Supplementation
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