Plain English Summary
Not provided at time of registration
Trial website
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 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 trial start date
29/03/2010
Overall trial end date
01/09/2011
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list