PRO-TECT II: Propofol cardioprotection for type II diabetics
| ISRCTN | ISRCTN70879185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70879185 |
| ClinicalTrials.gov number | NCT00734383 |
| Secondary identifying numbers | 210938 |
- Submission date
- 05/03/2010
- Registration date
- 11/03/2010
- Last edited
- 04/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Ansley
Scientific
Scientific
University of British Columbia
Department of Anesthesiology, Pharmacology and Therapeutics
Room 3300, 3rd Floor JPP
910 West 10th Ave
Vancouver
V5Z 4E3
Canada
| david.ansley@vch.ca |
Study information
| Study design | Interventional treatment randomised double-blind (subject, investigator) placebo-controlled parallel assignment efficacy study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Propofol cardioprotection during ischaemia-reperfusion to preserve myocardial function: an interventional randomised efficacy study |
| Study acronym | PRO-TECT II |
| Study objectives | 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. |
| Ethics approval(s) | University of British Columbia (UBC) Clinical Research Ethics Board, 22/09/2009, ref: H04-70456 |
| Health condition(s) or problem(s) studied | Cardioprotection for type II diabetics |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Propofol |
| Primary outcome measure | Peri-operative plasma 15 f2t isoprostane, a biologically active marker of oxidative stress. Timeframe: 24 hours post-operation. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2007 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 144 (study recruitment completed) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Canada
Study participating centre
University of British Columbia
Vancouver
V5Z 4E3
Canada
V5Z 4E3
Canada
Sponsor information
University of British Columbia (Canada)
University/education
University/education
Office of Research Services
#102 - 6190 Agronomy Road
Vancouver, British Columbia
V6T 1Z3
Canada
| Website | http://www.ors.ubc.ca/ |
|---|---|
"ROR" |
https://ror.org/03rmrcq20 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 210938)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No |
Editorial Notes
As of 20/12/2011, target number of participants have been modified to study recruitment completed.
Previous target number of participants: 144
