|
Welcome
|
|
23 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Cardiac Output Monitoring and Pre-operative Exercise Testing for Colorectal surgery |
| ISRCTN | ISRCTN14680495 |
| ClinicalTrials.gov identifier | |
| Public title | Cardiac Output Monitoring and Pre-operative Exercise Testing for Colorectal surgery |
| Scientific title | 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 |
| Acronym | COMPETE-C |
| Serial number at source | N/A |
| Study hypothesis |
Major colorectal surgery has traditionally been associated with a prolonged hospital stay and a moderate risk (1-5%) of mortality or serious cardiopulmonary morbidity.
Improved outcomes have been reported by international units and in NHS hospitals using a specific care bundle for major colorectal surgery: "Enhanced Recovery after Surgery" (ERAS). Such patient care pathways employ a multimodal approach to promote a rapid return to normal function. The Danish group around Kehlet, the originator of ERAS, claim that a hospital stay of 3 days or less for major colorectal surgery is now customary in their institutions whilst median stays using an ERAS approach of around 6 days have been produced elsewhere Controversies exist regarding intraoperative fluid management for major colorectal surgery. In recent decades fluid restriction has been advocated, however such an approach uniformly applied risks bowel ischaemia and other complications. Goal Directed Fluid therapy (GDT) refers to fluid management targeted toward improving the cardiac output to set levels, hence improving end organ perfusion. Minimally invasive devices are now available to measure cardiac stroke volume. Intra-operative GDT has been shown to reduce median hospital length of stay after major colorectal surgery from 9 to 7 days. This study aims to determine whether goal directed fluid therapy gives additional benefit to patients undergoing surgery within an ERAS programme, and aims to address the controversies regarding fluid management. As of 2007, Plymouth Hospitals NHS Trust provides a service to risk stratify patients undergoing elective surgery by Cardiopulmonary Exercise Testing (CPET), which can identify patients with a low cardiorespiratory reserve. These patients are at increased risk of complications after surgery. We have the capacity to perform CPET pre-operatively for all patients booked for elective major colonic or colorectal resection surgery. It may be that a subset of less fit patients may benefit more from GDT than a fitter cohort. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Cornwall and Plymouth Research Ethics Committee, approved on 09/09/2008 (ref: 08/H0203/159) |
| Study design | Double-blind parallel-arm randomised controlled single-centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Elective major colorectal surgery |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 10/03/2009 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 168 |
| 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 Chest Physicians (ACCP) recommendations. Anaerobic threshold will be determined by the V slope method with correlation with ventilatory equivalents. 2.Oesophageal Doppler monitoring (and Goal Directed Fluid Therapy) All patients will receive oesophageal Doppler monitoring throughout the operation. This monitoring will be carried out by a trained investigator. Patients in the intervention group will be given warmed colloid (6% Hydroxyethyl starch) before surgical incision to reach GDT goals as per a predetermined protocol and have additional fluid boli administered as dictated by this algorithm until cessation of surgery. The disposable oesophageal probe will be removed at the conclusion of surgery. The anaesthetist responsible for care will be blinded to the Doppler readings. The researcher carrying out the optimisation will be aware of all anaesthetic activity. |
| Primary outcome measure(s) |
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 outcome measure(s) |
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]). |
| Sources of funding |
1. Anaesthesia/ Association of Anaesthetists of Great Britain and Ireland (Ireland, UK) - Departmental project grant (main funding)
2. Plymouth Hospitals NHS Trust (UK) (ref: 08/H0203/159) 3. Fresenius Kabi UK (UK) - Unrestricted grant |
| Trial website | |
| Publications | 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21873370 |
| Contact name | Dr Gary Minto |
| Address |
Department of Anaesthesia
9th Floor Plateau Derriford Hospital |
| City/town | Plymouth |
| Zip/Postcode | PL68DH |
| Country | United Kingdom |
| Tel | +44 (0)1752 439205 |
| Fax | +44 (0)1752 763287 |
| gary.minto@phnt.swest.nhs.uk | |
| Sponsor | Plymouth Hospitals NHS Trust (UK) |
| Address |
c/o Lisa Vickers
R&D Manager Room N17 ITTC Building Tamar Science Park |
| City/town | Plymouth |
| Zip/Postcode | PL68BX |
| Country | United Kingdom |
| Sponsor website: | http://www.plymouthhospitals.nhs.uk |
| Date applied | 17/02/2009 |
| Last edited | 06/09/2011 |
| Date ISRCTN assigned | 20/04/2009 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|