Post-operative oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity
| ISRCTN | ISRCTN76894700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76894700 |
| Secondary identifying numbers | UK NIHR CSP 22346 |
- Submission date
- 22/01/2010
- Registration date
- 15/03/2010
- Last edited
- 12/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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 | Two-centre randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at https://www.ucl.ac.uk/anaesthesia/trials |
| Scientific title | Prospective randomised controlled trial of post-operative optimisation of oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity |
| Study acronym | POM-O |
| Study objectives | 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(s) | Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/58 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2010 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 204 |
| 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 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 |
| Key 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 |
| Date of first enrolment | 01/03/2010 |
| Date of final enrolment | 01/03/2013 |
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 Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint UCLH/UCL Biomedical Research Unit
1st Floor, Maples House
149 Tottenham Court Road
London
W1T 7NF
England
United Kingdom
| Phone | +44 (0)20 7380 6978 |
|---|---|
| n.mcnally@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/joint-rd-unit |
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Research organisation
Academy of Medical Sciences/Health Foundation (UK) - Clinician Scientist award to Dr GL Ackland
No information available
University College London Hospitals NHS Trust/University College London (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 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2015 | Yes | No | |
| Results article | sub-study results | 05/07/2021 | 12/07/2021 | Yes | No |
Editorial Notes
12/07/2021: Publication reference added.
