Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/03/2010
Date assigned
11/03/2010
Last edited
04/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Ansley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00734383

Protocol/serial number

210938

Study information

Scientific title

Propofol cardioprotection during ischaemia-reperfusion to preserve myocardial function: an interventional randomised efficacy study

Acronym

PRO-TECT II

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.

Ethics approval

University of British Columbia (UBC) Clinical Research Ethics Board, 22/09/2009, ref: H04-70456

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Propofol

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144 (study recruitment completed)

Participant 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

Recruitment start date

01/04/2007

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Canada

Trial participating centre

University of British Columbia
Vancouver
V5Z 4E3
Canada

Sponsor information

Organisation

University of British Columbia (Canada)

Sponsor details

Office of Research Services
#102 - 6190 Agronomy Road
Vancouver
British Columbia
V6T 1Z3
Canada

Sponsor type

University/education

Website

http://www.ors.ubc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 210938)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26721648

Publication citations

Additional files

Editorial Notes

As of 20/12/2011, target number of participants have been modified to study recruitment completed. Previous target number of participants: 144