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. - Peri-operative effects of dopexamine in patients with low AT

Phase 1

• Conditions: Patients undergoing scheduled resection for carcinoma of the colon, rectum, bladder, pancreas, stomach or kidney, who, after routine 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 method15, or with an AT of 11.0 -14.0 ml/min/m2 and ischaemic changes on ECG monitoring during testing or with a significant history of ischaemic heart disease (NYHA classification III and IV).

• Registration Number: EUCTR2006-002913-11-GB
• Lead Sponsor: York Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-30
• Study Completion: 2009-02-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

Patients undergoing scheduled resection for carcinoma of the colon, rectum, bladder, pancreas, stomach or kidney, who, after routine 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 method15, or with an AT of 11.0 -14.0 ml/min/m2 and ischaemic changes on ECG monitoring during testing or with a significant history of ischaemic heart disease (NYHA classification III and IV).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients less than 60 years of age unless they have significant co morbidities (ASA 3 or greater), patients having emergency or vascular procedures, those who are ASA grade 5, and patients who refuse or are unable to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified