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 designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Can be found at https://www.ucl.ac.uk/anaesthesia/trials
Scientific titleObservational cohort study of the immune, bioenergetic and microcirculatory response to cardiopulmonary exercise testing in healthy volunteers and non-cardiac surgical patients
Study acronymPOM-E
Study objectivesExercise-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) studiedPost-operative morbidity
InterventionVisit 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 typeProcedure/Surgery
Primary outcome measureMorbidity on post-operative day 3
Secondary outcome measuresImmune, bioenergetic, microcirculatory and cellular correlates associated with development of post-operative morbidity and length of hospital stay
Overall study start date29/03/2010
Completion date01/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants106
Key inclusion criteriaPatients 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 criteria1. 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 enrolment29/03/2010
Date of final enrolment01/09/2011

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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