COLLOID OR CRYSTALLOID FOR GOAL DIRECTED FLUID THERAPY IN PATIENTS UNDERGOING ELECTIVE COLORECTAL SURGERY: A RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL. - Colloid vs Crystalloid
- Conditions
- Bowel cancers and other bowel diseases requiring surgical intervention.
- Registration Number
- EUCTR2009-013872-29-GB
- Lead Sponsor
- York Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 202
Patients undergoing elective colorectal surgery, who after routine CPET testing at the Pre-assessment Clinic, have been found to have an Anaerobic Threshold (AT) less than or equal to 14.0 ml/kg/min as measured by the V-slope method.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients less than 55 years of age unless they have significant co-morbidities (ASA 3 or greater), patients having emergency procedures, those who are ASA grade 5, and patients who refuse or are unable to give informed consent.
Fluid overload (hyperhydration), especially in cases of pulmonary oedema and
congestive cardiac failure
Renal failure with oliguria or anuria not related to hypovolaemia
Patients receiving dialysis treatment
Intracranial bleeding
Known hypersensitivity to hydroxyethyl starches or gelatins
Patients with sodium overload
Patients with Hypertrophic Obstructive Cardiomyopathy, aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the trial is to test the hypothesis that maximising circulating volume intra-operatively with colloid suspended in balanced crystalloid solution reduces post-operative morbidity compared to balanced crystalloid alone, in medium-to-high-risk patients undergoing major elective colorectal surgery.;Secondary Objective: N/A;<br> Primary end point(s): Incidence of Gastrointestinal morbidity on the fifth postoperative day. Gastrointestinal morbidity is defined as the inability to tolerate either oral diet or nasogastric feed.<br> This has been chosen as, in a previous trial in this institution (submitted for publication), this measure correlated very closely with hospital length of stay and other measures of morbidity. It is easily measured.<br>
- Secondary Outcome Measures
Name Time Method