Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
19/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.crsu.ca

Contact information

Type

Scientific

Primary contact

Dr Peter T Choi

ORCID ID

Contact details

University of British Columbia
Department of Anesthesiology
Pharmacology & Therapeutics
910 West 10th Avenue
Room 3200
Vancouver
V5Z 4E3
Canada
+1 604-875-4111 (68433)
petert.choi@vch.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00221260

Protocol/serial number

MCT-73644

Study information

Scientific title

Peri-operative epidural in patients with moderate or high risk for cardiorespiratory events who are undergoing non-cardiothoracic surgery: a randomised controlled trial

Acronym

POET

Study hypothesis

Enrolling patients into the above study is still feasible in the current clinical setting.

Ethics approval

Ethics approval received from the Clinical Research Ethics Board of the University of British Columbia on the 31st March 2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Postoperative cardio-respiratory complications

Intervention

Control:
Intraoperative general anesthesia and postoperative intravenous narcotic analgesia.

Intervention:
Intraoperative neuraxial (epidural or spinal) ± general anesthesia and postoperative epidural analgesia.

Trial details received: 12 September 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Rates of enrolment, follow-up, and crossover.

Secondary outcome measures

1. Combined 30-day outcome of all-cause mortality, nonfatal myocardial infarction, cardiac arrest, postoperative pneumonia, and respiratory failure
2. Other clinical outcomes: deep vein thrombosis, pulmonary embolism, transient ischemic attacks, stroke, and congestive heart failure during first 30 post-operative days
3. Safety outcomes: clinically significant bradycardia or hypotension

Overall trial start date

01/05/2005

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient undergoing non-cardiopulmonary surgery who:
1. Is greater than or equal to 45 years old, either sex
2. Has an expected length of stay greater than or equal to 48 hours
3. Is undergoing a procedure amenable to postoperative epidural analgesia
4. Fulfils any six criteria for moderate to high cardiorespiratory risk

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Is pregnant or planning to become pregnant before surgery
2. Has a contraindication to epidural analgesia
3. Had a prior adverse reaction to local anesthetics or narcotics
4. Had coronary artery bypass graft surgery with complete revascularisation in the preceding 5 years and has no evidence of cardiac ischemia since the procedure
5. Has pneumonia in the preoperative period
6. Is intubated or mechanically ventilated prior to surgery
7. Has concomitant life-threatening disease likely to limit life expectancy to less than 30 days

Recruitment start date

01/05/2005

Recruitment end date

30/04/2006

Locations

Countries of recruitment

Canada

Trial participating centre

University of British Columbia
Vancouver
V5Z 4E3
Canada

Sponsor information

Organisation

Vancouver Coastal Health Research Institute, University of British Columbia (Canada)

Sponsor details

828 West 10th Avenue
Vancouver
V5Z 1L8
Canada
cheryl.davies@vch.ca

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-73644)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/19247497

Publication citations

  1. Results

    Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H, Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study., PLoS ONE, 2009, 4, 2, e4644, doi: 10.1371/journal.pone.0004644.

Additional files

Editorial Notes