Condition category
Surgery
Date applied
22/01/2010
Date assigned
15/03/2010
Last edited
26/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.ucl.ac.uk/anaesthesia/trials

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

http://www.ucl.ac.uk/joint-rd-unit

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

Publication citations

Additional files

Editorial Notes