Randomised controlled, double blinded single centre trial to assess the effects of peri-operative dopexamine on morbidity after major abdominal surgery in patients with low anaerobic threshold

ISRCTN	ISRCTN33549216
DOI	https://doi.org/10.1186/ISRCTN33549216
Protocol serial number	DOP06
Sponsor	York Hospitals NHS Trust (UK)
Funder	Association of Anaesthetists (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Simon Davies
Scientific

York Hospital
Wigginton Road
York
YO31 8HE
United Kingdom

Phone	+44 (0) 190 463 1313
Email	simon.davies@york.nhs.uk

Primary study design	Interventional
Study design	Randomised, controlled, double blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approved by York Research Ethics Committee.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Dopexamine
Primary outcome measure(s)	Morbidity at five, ten, and 15 days using the Post-Operative Morbidity Score (POMS) score.
Key secondary outcome measure(s)	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
Completion date	01/02/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	124
Key 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).
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/02/2009

York Hospital

York
YO31 8HE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No