Post-Operative Morbidity-Exercise: pre-operative exercise biology and post-operative outcomes
ISRCTN | ISRCTN90019424 |
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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
Contact information
Dr Gareth Ackland
Scientific
Scientific
Wolfson Institute for Biomedical Research
University College London
Gower Street
London
WC1E 6BT
United Kingdom
g.ackland@ucl.ac.uk |
Study information
Study design | Observational cohort study |
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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 |
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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
WC1E 6BT
United Kingdom
Sponsor information
University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
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 |
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n.mcnally@ucl.ac.uk | |
Website | http://www.uclh.nhs.uk/ |
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 | |
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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.