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ISRCTN
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ISRCTN41882213
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ClinicalTrials.gov identifier
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Public title
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Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery
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Scientific title
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Colloid or crystalloid for goal directed fluid therapy in patients undergoing elective colorectal surgery: a randomised, double-blind controlled trial
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Acronym
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N/A
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Serial number at source
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YOR-A01243
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Leeds (West) Research Ethics Committee approved on the 8th September 2009 (ref: 09/H1307/77)
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Study design
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Single-centre randomised controlled double-blind trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Elective surgical resection of the colon
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2009
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Anticipated end date
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01/10/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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202
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Interventions
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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.
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Primary outcome measure(s)
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Incidence of gastrointestinal morbidity on day 5 following surgery.
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Secondary outcome measure(s)
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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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Sources of funding
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Fresenius Kabi (Germany) - Unrestricted research grant
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Trial website
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Publications
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Contact name
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Dr
Jonathan
Wilson
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Address
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Department of Anaesthesia
York District Hospital
Wiggington Road
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City/town
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York
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Zip/Postcode
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YO31 8HE
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Country
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United Kingdom
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Email
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David.Yates@York.NHS.UK
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Sponsor
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York Hospitals NHS Foundation Trust (UK)
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Address
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Wiggington Road
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City/town
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York
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Zip/Postcode
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YO31 8HE
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Country
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United Kingdom
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Sponsor website:
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http://www.yorkhospitals.nhs.uk/
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Date applied
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17/09/2009
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Last edited
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15/12/2009
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Date ISRCTN assigned
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15/12/2009
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