Contact information
Type
Scientific
Primary contact
Dr Simon Davies
ORCID ID
Contact details
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0) 190 463 1313
simon.davies@york.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DOP06
Study information
Scientific title
Acronym
Study hypothesis
That using a combination of fluid and dopexamine will reduce the post operative morbidity of patients undergoing elective major abdominal surgery who have a low anaerobic threshold.
Ethics approval
Approved by York Research Ethics Committee.
Study design
Randomised, controlled, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Major Abdominal Surgery
Intervention
As of 12/03/2008 the anticipated end date of this trial was extended to 1st February 2009. The previous anticipated end date was 1st February 2008.
Infusion of dopexamine at 0.5 mcg/kg/min for 24 hours. The control group receives placebo (normal saline) as an infusion for 24 hours.
Intervention type
Drug
Phase
Not Specified
Drug names
Dopexamine
Primary outcome measure
Morbidity at five, ten, and 15 days using the Post-Operative Morbidity Score (POMS) score.
Secondary outcome measures
1. Length of stay in hospital after surgery
2. Recovery parameters (drinking, eating, mobilising)
3. Incidence of post-operative complications
4. Peri-operative haemodynamic variables (heart rate, blood pressure, Central Venous Pressure [CVP])
5. Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) score for surgical risk assessment
6. Oxygen delivery
Overall trial start date
01/09/2006
Overall trial end date
01/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing scheduled resection for carcinoma of the colon, rectum, bladder, pancreas, stomach or kidney, who, after routine Cardiopulmonary exercise (CPX) testing at the Pre-assessment Clinic, have been found to have an Anaerobic Threshold (AT) less than or equal to 11.0 ml/min/m2 as measured by the V-slope method 15, or with an AT of 11.0 -14.0 ml/min/m2 and ischaemic changes on Electrocardiogram (ECG) monitoring during testing or with a significant history of ischaemic heart disease (New York Heart Association [NYHA] classification III and IV).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
124
Participant exclusion criteria
1. Less than 60 years of age unless they have significant co-morbidities (American Society of Anaesthesiologists (ASA) score three or greater)
2. Having emergency or vascular procedures
3. ASA grade five
4. Refuse or are unable to give informed consent
5. Hypertrophic Obstructive Cardiomyopathy, aortic stenosis, phaeochromocytoma, a low platelet count, or have used a monoamine oxidase inhibitor within the last 14 days
Recruitment start date
01/09/2006
Recruitment end date
01/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
York Hospital
York
YO31 8HE
United Kingdom
Sponsor information
Organisation
York Hospitals NHS Trust (UK)
Sponsor details
York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom
+44 (0) 190 463 1313
caroline.mozley@york.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Association of Anaesthetists (UK)
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21048092
Publication citations
-
Results
Davies SJ, Yates D, Wilson RJ, Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery., Anesth. Analg., 2011, 112, 1, 130-138, doi: 10.1213/ANE.0b013e3181fcea71.