Condition category
Surgery
Date applied
01/08/2006
Date assigned
18/08/2006
Last edited
19/10/2012
Prospective/Retrospective
Prospectively 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 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 measures

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

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

http://www.yorkhealthservices.org/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21048092

Publication citations

  1. 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.

Additional files

Editorial Notes