Post-Operative Morbidity-Exercise: pre-operative exercise biology and post-operative outcomes

ISRCTN	ISRCTN90019424
DOI	https://doi.org/10.1186/ISRCTN90019424
Secondary identifying numbers	N/A

Submission date: 08/03/2010
Registration date: 27/04/2010
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Gareth Ackland
Scientific

Wolfson Institute for Biomedical Research
University College London
Gower Street
London
WC1E 6BT
United Kingdom

Email	g.ackland@ucl.ac.uk

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Can be found at https://www.ucl.ac.uk/anaesthesia/trials
Scientific title	Observational cohort study of the immune, bioenergetic and microcirculatory response to cardiopulmonary exercise testing in healthy volunteers and non-cardiac surgical patients
Study acronym	POM-E
Study objectives	Exercise-induced changes in immune, autonomic and cardiovascular physiology are predictive of post-operative morbidity independent of exercise capacity.
Ethics approval(s)	Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/59
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	29/03/2010
Completion date	01/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	106
Key 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
Key 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
Date of first enrolment	29/03/2010
Date of final enrolment	01/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Wolfson Institute for Biomedical Research

London
WC1E 6BT
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Joint UCLH/UCL Biomedical Research Unit
1st Floor, Maples House
149 Tottenham Court Road
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)20 7380 6978
Email	n.mcnally@ucl.ac.uk
Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Government

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

No information available

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

No information available

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

No information available

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

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.