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Cardiac Output Monitoring and Pre-operative Exercise Testing for Colorectal surgery

Amongst patients having major elective colorectal surgery does intraoperative goal directed fluid therapy particularly decrease postoperative hospital length of stay in patients who are categorised "high risk" on the basis of a preoperative cardiopulmonary exercise test result? - a double-blind parallel-arm randomised controlled single-centre trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14680495
Enrollment
168
Registered
2009-04-20
Start date
2009-03-10
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Elective major colorectal surgery Surgery

Interventions

1. Cardiopulmonary Exercise Test (CPET) The CPET test will be done in accordance with the consensus protocol from UK centre with reference to American Thoracic Society (ATS)/ American College of Ches

Sponsors

Plymouth Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age 18 and older 2. Elective colorectal surgical patients scheduled for major surgery 3. Patients with a measurable anaerobic threshold (AT) above 8 ml O2/kg/min

Exclusion criteria

Exclusion criteria: Absolute: 1. Unwillingness to participate 2. Inability to perform the tests and consent within the timetable for elective surgery 3. Measured Anaerobic Threshold below 8 ml O2/kg/min. Such patients will be considered to be extremely unfit and as such will not be suitable for inclusion in the trial. 4. Withdrawn by anaesthetist or surgeon 5. Acute myocardial infarction (3?5 days) 6. Unstable angina 7. Uncontrolled arrhythmias causing symptoms or haemodynamic compromise 8. Syncope 9. Active endocarditis 10. Acute myocarditis or pericarditis 11. Symptomatic severe aortic stenosis 12. Uncontrolled heart failure 13. Acute pulmonary embolus or pulmonary infarction 14. Thrombosis of lower extremities 15. Suspected dissecting aneurysm 16. Uncontrolled asthma 17. Pulmonary edema 18. Room air desaturation at rest <85% 19. Respiratory failure 20. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis) 21. Severe oesophageal disease 22. Recent oesophageal or upper airway surgery 23. Systemic steroid medication 24. Bleeding diathesis Relative: 25. Left main coronary stenosis or its equivalent 26. Moderate stenotic valvular heart disease 27. Severe untreated arterial hypertension at rest (200 mm Hg systolic, 120 mm Hg diastolic) 28. Tachyarrhythmias or bradyarrhythmias 29. High-degree atrioventricular block 30. Hypertrophic cardiomyopathy 31. Significant pulmonary hypertension 32. Advanced or complicated pregnancy 33. Electrolyte abnormalities 34. Orthopaedic impairment that compromises exercise performance

Design outcomes

Primary

MeasureTime frame
Amongst patients having major elective colorectal surgery under an Enhanced Recovery after Surgery (ERAS) pathway: 1. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?high risk? on the basis of a preoperative cardiopulmonary exercise test result? 2. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in patients who are categorised ?standard risk? on the basis of a preoperative cardiopulmonary exercise test result? 3. Does intraoperative goal directed fluid therapy decrease postoperative hospital length of stay when compared with standard therapy alone in all patients?

Secondary

MeasureTime frame
Amongst patients having major elective colorectal surgery under an ERAS pathway, does intraoperative goal directed fluid therapy make a difference to the following when compared with standard therapy alone?: 1. Peri-operative mortality (30 days) 2. Postoperative hypotension 3. Postoperative fluid requirement 4. Return of gastrointestinal function 5. Tolerance of diet Secondary outcomes 2-5 will be assessed every post-op day until the participants meet discharge criteria (median length of stay for this surgery is currently 9 days [as of 17/02/2009]).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026