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Post-operative oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity

Prospective randomised controlled trial of post-operative optimisation of oxygen delivery in patients undergoing major non-cardiac surgery to reduce morbidity

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76894700
Enrollment
204
Registered
2010-03-15
Start date
2010-03-01
Completion date
Unknown
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative morbidity Surgery Morbidity

Interventions

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.

Sponsors

University College London Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Reduction in post-operative morbidity on day 3 post-operatively as defined by the Post-Operative Morbidity Survey (POMS)

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026