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10 February 2012
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| [ Print-friendly version ] |
| PRO-TECT II: Propofol cardioprotection for type II diabetics |
| ISRCTN | ISRCTN70879185 |
| ClinicalTrials.gov identifier | NCT00734383 |
| Public title | PRO-TECT II: Propofol cardioprotection for type II diabetics |
| Scientific title | Propofol cardioprotection during ischaemia-reperfusion to preserve myocardial function: an interventional randomised efficacy study |
| Acronym | PRO-TECT II |
| Serial number at source | 210938 |
| Study hypothesis |
Elevated oxidant stress may occur during myocardial ischaemia-reperfusion, influencing release and action of tumour necrosis factor-alpha (TNF-a), which inhibits cardioprotective endothelial NOS (eNOS), enhances endothelin-1 (ET-1) formation, and promotes the conversion of nitric oxide to cardiotoxic peroxynitrite. These factors cause cardiac dysfunction. Effective antioxidant intervention during ischaemia-reperfusion will preserve myocardial function.
As of 20/12/2011, target number of participants have been modified to study recruitment completed. Previous target number of participants: 144 |
| Lay summary | Not provided at time of registration |
| Ethics approval | University of British Columbia (UBC) Clinical Research Ethics Board approved on the 22nd September 2009 (ref: H04-70456). |
| Study design | Interventional treatment randomised double-blind (subject, investigator) placebo-controlled parallel assignment efficacy study |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Cardioprotection for type II diabetics |
| Participants - inclusion criteria |
1. Adult patients aged 18 - 80 years, either sex
2. Undergoing primary coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) at the Vancouver General Hospital 3. Require revascularisation of three or more coronary arteries with an anticipated aortic cross-clamp time of at least 60 minutes 4. Have a pre-operative systolic blood pressure above 90 mmHg in the absence of inotropic or mechanical support |
| Participants - exclusion criteria |
1. Type I diabetes mellitus (defined as an established history and diagnosis of diabetes mellitus requiring insulin therapy from the time of diagnosis)
2. Co-existing valvular heart disease (moderate to severe aortic stenosis or mitral regurgitation) 3. Acute or evolving myocardial infarction 4. History of hypersensitivity to propofol or any of its formulation components 5. Taking non-steroidal anti-inflammatory drugs, vitamin C, or vitamin E within five days of surgery |
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/03/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 144 (Study recruitment completed). |
| Interventions |
1. Experimental - propofol cardioprotection:
Ten minutes prior to initiation of CPB, we will stop delivery of isoflurane, inject 1 mg/kg intravenous (iv) and then continuously infuse propofol at 120 µg/kg/min iv until 15 minutes after release of the aortic cross clamp (reperfusion). 2. Experimental - volatile anaesthesia preconditioning: Anaesthesia will be maintained using an inspired concentration of isoflurane between 0.5 - 2% before, during, and after CPB, without administration of propofol. For ten minutes prior to the initiation of CPB we will deliver Isoflurane 2.5% end tidal then resume maintenance anaesthesia as described. Total duration of treatment and follow up is currently up to 30 days post-operatively at the current time. |
| Primary outcome measure(s) | Peri-operative plasma 15 f2t isoprostane, a biologically active marker of oxidative stress. Time frame: 24 hours post-operation. |
| Secondary outcome measure(s) |
Biochemical outcomes:
1. Plasma total antioxidant concentration 2. Systemic and coronary sinus levels of troponin I, ET-1, TNF-a, and peroxynitrite formation in blood 3. Gene and protein expression of inducible NOS (iNOS) and eNOS 4. Protein expression of Akt and its activation 5. Evidence of superoxide formation in atrial tissue Clinical outcomes: 6. Incidence rate of low cardiac output syndrome during the first 6 hours after surgery 7. Incidence rate of inotropic support or intra-aortic balloon counterpulsation required for greater than 30 minutes duration to treat low cardiac output syndrome 8. Intensive care unit and hospital lengths of stay |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 210938) |
| Trial website | |
| Publications | |
| Contact name | Dr David Ansley |
| Address |
University of British Columbia
Department of Anesthesiology, Pharmacology and Therapeutics Room 3300, 3rd Floor JPP 910 West 10th Ave |
| City/town | Vancouver |
| Zip/Postcode | V5Z 4E3 |
| Country | Canada |
| david.ansley@vch.ca | |
| Sponsor | University of British Columbia (Canada) |
| Address |
Office of Research Services
#102 - 6190 Agronomy Road |
| City/town | Vancouver, British Columbia |
| Zip/Postcode | V6T 1Z3 |
| Country | Canada |
| Sponsor website: | http://www.ors.ubc.ca/ |
| Date applied | 05/03/2010 |
| Last edited | 18/01/2012 |
| Date ISRCTN assigned | 11/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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