Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery

Completed

Conditions: Elective surgical resection of the colon
Digestive System

Registration Number: ISRCTN41882213

Lead Sponsor: York Hospitals NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 202

Inclusion Criteria

Patients (both males and females) over 55 years of age undergoing elective colorectal surgery, who after routine cardiopulmonar exercise testing (CPET) at the Pre-assessment Clinic, have been found to have an oxygen uptake at anaerobic threshold (AT) less than or equal to 14.0 ml/kg/min as measured by the V-slope method.

Exclusion Criteria

1. Patients less than 55 years of age
2. Patients having emergency procedures
3. Those who are American Society of Anaesthesiologists (ASA) classification grade 5
4. Patients who refuse or are unable to give informed consent
5. Renal failure with oliguria or anuria not related to hypovolaemia
6. Patients receiving dialysis treatment
7. Intracranial bleeding
8. Known hypersensitivity to hydroxyethyl starches or gelatins
9. Patients with sodium overload
10. Patients who have had inadequate time (less than 24 hours) to consider the Patient Information Leaflet
11. Patients with hypertrophic obstructive cardiomyopathy (HOCM), aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of gastrointestinal morbidity on day 5 following surgery.

Secondary Outcome Measures

Name	Time	Method
1. Incidence of post operative complications during hospital stay<br>2. Morbidity at 1, 3, 5, 8, 10 days measured by Postoperative Morbidity Survey<br>3. Length of stay in hospital after surgery<br>4. Recovery parameters (time to eating, drinking, and mobilising after surgery)<br>5. Peri-operative haemodynamic variables (central venous pressure [CVP], heart rate, blood pressure, oxygen delivery, stroke volume variation)<br>6. Cost effectiveness of the intervention<br>7. Measurement of inflammatory markers<br>8. Use of additional inotropic support<br>9. Use of rescue colloid boluses