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).
Conditions
Interventions
Trade Name: Dopacard
Product Name: Dopexamine hydrochloride
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: DOPEXAMINE HYDROCHLORIDE
Sponsors
York Hospitals NHS Trust
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess morbidity at 1,3, 5, 8,10, 12 and 15 days using POMS score; Secondary Objective: To identify differences in 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, CVP) 5. POSSUM score for surgical risk assessment. 6. Oxygen delivery ;Primary end point(s): 1. Morbidity at 1,3,5,8 10,12 and 15 days | — |
Countries
United Kingdom
Outcome results
None listed