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

Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery: a randomised, double-blind controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41882213

Enrollment

202

Registered

2009-12-15

Start date

2009-10-01

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 surgical resection of the colon Digestive System

Interventions

Patients will receive either Volulyte™, a colloid in balanced salt solution or Hartmann's Solution for intra-operative haemodynamic optimisation guided by stroke volume variation. This will be given

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Incidence of gastrointestinal morbidity on day 5 following surgery.	—

Secondary

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

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

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