Condition category
Surgery
Date applied
08/03/2010
Date assigned
27/04/2010
Last edited
05/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.ucl.ac.uk/anaesthesia/trials

Contact information

Type

Scientific

Primary contact

Dr Gareth Ackland

ORCID ID

Contact details

Wolfson Institute for Biomedical Research
University College London
Gower Street
London
WC1E 6BT
United Kingdom
g.ackland@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Observational cohort study of the immune, bioenergetic and microcirculatory response to cardiopulmonary exercise testing in healthy volunteers and non-cardiac surgical patients

Acronym

POM-E

Study hypothesis

Exercise-induced changes in immune, autonomic and cardiovascular physiology are predictive of post-operative morbidity independent of exercise capacity.

Ethics approval

Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/59

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Can be found at https://www.ucl.ac.uk/anaesthesia/trials

Condition

Post-operative morbidity

Intervention

Visit 0 (baseline): screening for inclusion/exclusion criteria; informed consent; demographic data collection
Visit 1 (within 3 weeks): cardiopulmonary exercise test; blood samples, microvascular and cardiopulmonary data collected pre- and 60 minutes post-exercise
Visit 2 (post-operative day 2): blood samples, microvascular and cardiopulmonary data collected pre- and 60 minutes post-exercise
Visit 3 (post-operative day 3): morbidity documented
Visit 4 (post-operative day 5): morbidity documented
Visit 5 (post-operative day 8): morbidity documented
Visit 6 (post-operative day 15): morbidity documented
Visit 7 (day of discharge): length of stay recorded

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Morbidity on post-operative day 3

Secondary outcome measures

Immune, bioenergetic, microcirculatory and cellular correlates associated with development of post-operative morbidity and length of hospital stay

Overall trial start date

29/03/2010

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing major elective major surgical procedures that are associated with a high incidence of post-operative morbidity (abdominal/oesophageal/hepatic resection/gynaecology/urological reconstructive surgery) and who meet the following criteria:
1. American Society of Anaesthesiologists (ASA) risk grade 3 - 4
2. Aged greater than 50 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

106

Participant exclusion criteria

1. Acute myocardial ischaemia (contraindication for inotropic support)
2. Acute arrhythmias (contraindication for inotropic support)
3. Pregnancy (lithium-based cardiac output monitoring device)
4. Patients receiving palliative treatment only

Recruitment start date

29/03/2010

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wolfson Institute for Biomedical Research
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

Joint UCLH/UCL Biomedical Research Unit
1st Floor
Maples House
149 Tottenham Court Road
London
WC1E 6BT
United Kingdom
+44 (0)20 7380 6978
n.mcnally@ucl.ac.uk

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Government

Funder name

Academy of Medical Sciences/The Health Foundation (UK) - Clinician Scientist Award to Dr GL Ackland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University College London Hospitals NHS Foundation Trust (UK) - Comprehensive Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University College London (UK) - Centre for Anaesthesia, Critical Care and Pain Medicine

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

Publication citations

Additional files

Editorial Notes