COLLOID OR CRYSTALLOID FOR GOAL DIRECTED FLUID THERAPY IN PATIENTS UNDERGOING ELECTIVE COLORECTAL SURGERY: A RANDOMISED, DOUBLE-BLIND CONTROLLED TRIAL. - Colloid vs Crystalloid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013872-29-GB

Enrollment

202

Registered

2009-07-23

Start date

2009-08-27

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Bowel cancers and other bowel diseases requiring surgical intervention.

Interventions

Trade Name: Volulyte Product Name: Volulyte 6% solution for infusion Product Code: Volulyte Pharmaceutical Form: Intravenous infusion T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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; 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. 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.	—

Measure

Time frame

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; 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. 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.

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Countries

United Kingdom

Outcome results

None listed

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