Coronary Artery Bypass Clinical Trial
— RICARDOOfficial title:
Effect of Remote Ischemic Conditioning on Ischemia and Reperfusion Injury in Patients Submitted to Coronary Artery Bypass Grafting.
This study evaluates the addition of remote ischemic preconditioning and postconditioning to standard myocardial protection protocol in patients submitted to off - pump coronary artery bypass grafting in a prospective, 1:1 randomized, double blind fashion. An interventional group will receive remote ischemic preconditioning 24-hours before OP-CABG, immediately before surgery and within 60 minutes following surgery by means of lower limb ischemia achieved by pressure cuff inflation, whereas control group will receive sham procedure perioperatively.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: Patients qualified to coronary artery bypass grafting according to ESC/EACTS Guidelines of myocardial revascularization, suffering from: - Multivessel coronary artery disease amenable for surgical treatment - Negative history of previous cardiac or vascular surgery in childhood and afterwards. - Negative history of active neoplastic disease, neither past medical history of oncological treatment - Patients with non insulin dependent diabetes mellitus treated chronically with oral derivatives of sulfonylourea such as but not limited to: glibenclamide. Exclusion Criteria: Patients suffering from acute insuficiency of any organ/ system and those suffering from end stage organ failure such as: - Chronic renal disease - KDOQI stage = 3; - Chronic renal failure class A by Child - Pugh'a; - Chronic respiratory failure (type I and II according to Campbell et al. and type I according to Wood et al.); - Chronic intermittent claudication class 2A according to Fontaine; |
Country | Name | City | State |
---|---|---|---|
Poland | Medinet Heart Centre | Nowa Sol | Lubuskie |
Lead Sponsor | Collaborator |
---|---|
Medinet Heart Centre |
Poland,
Marczak J, Nowicki R, Kulbacka J, Saczko J. Is remote ischaemic preconditioning of benefit to patients undergoing cardiac surgery? Interact Cardiovasc Thorac Surg. 2012 May;14(5):634-9. doi: 10.1093/icvts/ivr123. Epub 2012 Jan 26. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative myocardial necrosis | Serial mesurements of High - Sensitive Troponin T release | 72 hours postoperatively | |
Primary | Postoperative kidney injury | Serial measurements of estimated glomerular filtration rate by creatinine | 7 days postoperatively | |
Secondary | Perioperative mortality | 30-day all cause mortality | 30 days postoperatively | |
Secondary | Perioperative myocardial infarction | 30-day myocardial infarction | 30 days postoperatively | |
Secondary | Postoperative Acute Kidney Injury | Prevalence of acute kidney injury according to Society of Thoracic Surgeons definitions of outcomes. | 30 days |
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