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ISRCTN
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ISRCTN76894700
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ClinicalTrials.gov identifier
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Public title
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Post-operative oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity
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Scientific title
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Prospective randomised controlled trial of post-operative optimisation of oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity
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Acronym
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POM-O
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Serial number at source
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UK NIHR CSP 22346
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Outer South East London REC - South London REC Office (4) approved on the 29th December 2009 (ref: 09/H0805/58)
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Study design
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Two-centre randomised double-blind placebo-controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Post-operative morbidity
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2010
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Anticipated end date
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01/03/2013
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Status of trial
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Ongoing |
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Patient information material
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Can be found at https://www.ucl.ac.uk/anaesthesia/trials
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Target number of participants
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204
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Interventions
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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.
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Primary outcome measure(s)
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Reduction in post-operative morbidity on day 3 post-operatively as defined by the Post-Operative Morbidity Survey (POMS)
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Academy of Medical Sciences/Health Foundation (UK) - Clinician Scientist award to Dr GL Ackland
2. University College London Hospitals NHS Trust/University College London (UK) - Comprehensive Biomedical Research Centre
3. University College London (UK) - Centre for Anaesthesia, Critical Care and Pain Medicine
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Trial website
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https://www.ucl.ac.uk/anaesthesia/trials
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Publications
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Contact name
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Dr
Gareth
Ackland
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Address
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Wolfson Institute for Biomedical Research,
University College London,
Gower Street
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City/town
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London
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Zip/Postcode
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WC1E 6BT
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Country
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United Kingdom
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Email
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g.ackland@ucl.ac.uk
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Sponsor
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University College London Hospitals NHS Trust (UK)
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Address
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Joint UCLH/UCL Biomedical Research Unit
1st Floor, Maples House
149 Tottenham Court Road
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City/town
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London
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Zip/Postcode
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W1T 7NF
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Country
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United Kingdom
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Tel
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+44 (0)20 7380 6978
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Email
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n.mcnally@ucl.ac.uk
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Sponsor website:
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http://www.ucl.ac.uk/joint-rd-unit
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Date applied
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22/01/2010
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Last edited
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15/03/2010
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Date ISRCTN assigned
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15/03/2010
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