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
UK NIHR CSP 22346
Study information
Scientific title
Prospective randomised controlled trial of post-operative optimisation of oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity
Acronym
POM-O
Study hypothesis
Enhancing oxygen delivery to a pre-determined target immediately post-operatively reduces post-operative morbidity and length of hospital stay in high risk surgical patients.
Ethics approval
Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/58
Study design
Two-centre randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at https://www.ucl.ac.uk/anaesthesia/trials
Condition
Post-operative morbidity
Intervention
Patients randomised to undergo fluid with/without inotropic support (goal-directed therapy) to achieve pre-defined oxygen delivery target for 6 hours immediately post-operatively.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Reduction in post-operative morbidity on day 3 post-operatively as defined by the Post-Operative Morbidity Survey (POMS)
Secondary outcome measures
Measured pre-operatively and at 1, 2, 5 and 8 days post-operatively:
1. Immune, bioenergetic, microcirculatory and cellular correlates associated with development of post-operative morbidity
2. Length of hospital stay
Overall trial start date
01/03/2010
Overall trial end date
01/03/2013
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 risk grade 3 - 4
2. Aged greater than 50 years, either sex
3. Greater than two risk factors defined by the Revised Cardiac Risk Index
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
204
Participant exclusion criteria
1. Concurrent lithium therapy (incompatible with cardiac output monitoring device)
2. Acute myocardial ischaemia (contraindication for inotropic support)
3. Acute arrhythmias (contraindication for inotropic support)
4. Pregnancy (lithium-based cardiac output monitoring device)
5. Patients receiving palliative treatment only
Recruitment start date
01/03/2010
Recruitment end date
01/03/2013
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 Trust (UK)
Sponsor details
Joint UCLH/UCL Biomedical Research Unit
1st Floor
Maples House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
+44 (0)20 7380 6978
n.mcnally@ucl.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Academy of Medical Sciences/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 Trust/University College London (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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25523407