Condition category
Digestive System
Date applied
17/09/2009
Date assigned
15/12/2009
Last edited
17/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Wilson

ORCID ID

Contact details

Department of Anaesthesia
York District Hospital
Wiggington Road
York
YO31 8HE
United Kingdom
David.Yates@York.NHS.UK

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

YOR-A01243

Study information

Scientific title

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

Acronym

Study hypothesis

Major surgery generates a strong systemic inflammatory response that in turn leads to an increase in oxygen demand in the peri-operative period. This substantial increase in oxygen demand is normally met by increases in the volume of blood that the heart pumps out each minute (cardiac output) and by increasing the amount of oxygen that the tissues extract from the blood. Most patients can meet this increased oxygen demand by increasing cardiac output and will usually do well after surgery. To increase cardiac output in an efficient way, i.e. by making the heart beat more powerfully rather than just faster, the patient needs to have an optimum amount of blood in their circulatory system. Recent studies have demonstrated that morbidity rates and length of stays in hospital can be improved by giving each individual patient just the right amount of intravenous fluid during their operation.

To date, no-one has proven in a randomised trial which type of intravenous fluid anaesthetists should be using to do this. Therefore we propose to carry out a randomised, blinded study looking into the differences between using crystalloid or colloid for perioperative haemodynamic optimisation in a population of medium to high risk patients having colorectal surgery.

Ethics approval

Leeds (West) Research Ethics Committee approved on the 8th September 2009 (ref: 09/H1307/77)

Study design

Single-centre randomised controlled double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective surgical resection of the colon

Intervention

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 blinded as 250 ml boluses. Intervention will take place during the operation only. Follow up will be for 15 days or until hospital discharge.

Intervention type

Drug

Phase

Not Specified

Drug names

Volulyte™, Hartmann's Solution

Primary outcome measures

Incidence of gastrointestinal morbidity on day 5 following surgery.

Secondary outcome measures

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

Overall trial start date

01/10/2009

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

202

Participant 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

Recruitment start date

01/10/2009

Recruitment end date

01/10/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

York Hospitals NHS Foundation Trust (UK)

Sponsor details

Wiggington Road
York
YO31 8HE
United Kingdom

Sponsor type

Government

Website

http://www.yorkhospitals.nhs.uk/

Funders

Funder type

Industry

Funder name

Fresenius Kabi (Germany) - Unrestricted research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24056586

Publication citations

  1. Results

    Yates DR, Davies SJ, Milner HE, Wilson RJ, Crystalloid or colloid for goal-directed fluid therapy in colorectal surgery., Br J Anaesth, 2014, 112, 2, 281-289, doi: 10.1093/bja/aet307.

Additional files

Editorial Notes