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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33549216
Enrollment
124
Registered
2006-08-18
Start date
2006-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Abdominal Surgery Surgery Major Abdominal Surgery

Interventions

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 ho

Sponsors

York Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Morbidity at five, ten, and 15 days using the Post-Operative Morbidity Score (POMS) score.

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026