Post-operative complications in patients who undergo major surgery
Conditions
Interventions
Trade Name: Dopacard
Pharmaceutical Form:
INN or Proposed INN: DOPEXAMINE
CAS Number: 86197479
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Queen Mary's, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients undergoing major abdominal surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes will be eligible for recruitment provided they satisfy one of the following criteria: Age 65 years and over Or… Age 50-64 plus, one or more of: - non-elective surgery; - acute or chronic renal impairment (serum creatinine >130 µmol/l) - diabetes mellitus - presence of a risk factor for cardiac or respiratory disease 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: • Refusal of consent • Patients receiving palliative treatment only (likely to die within 30 days) • Acute myocardial ischaemia (within 30 days prior to randomisation) • Acute pulmonary oedema (within 7 days prior to randomisation) • Septic shock at time of enrolment • Thrombocytopenia (platelet count <50 x 109 l-1) • Patients who are receiving monoamine oxidase inhibitors (MAOIs) • Phaeochromocytoma • Severe Left ventricular outlet obstruction eg due to hypertrophic obstructive cardiomyopathy or severe aortic stenosis • Known hypersensitivity to dopexamine hydrochloride or disodium edentate • Pregnancy at time of enrolment • Failure to meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Difference in 30 day post-operative morbidity between study groups;Main Objective: To establish whether the use of minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, combined with low dose dopexamine infusion will reduce the number of patients who experience complications or death within 30 days following major surgery involving the gastro-intestinal tract.; Secondary Objective: • Difference in 30 day post-operative mortality between treatment arms • Difference in morbidity identified with the Post-Operative Morbidity Survey (POMS) for patients still in hospital on day 7 following randomisation • Difference in the number of patients developing infectious complications within 30 days following randomisation • Difference in duration of post-operative hospital stay • Difference in 30 day critical care free days (i.e. alive and not in critical care) • Difference in 180 day post-operative mortality • Difference in cost-effectiveness • Difference in healthcare costs | — |
Countries
United Kingdom
Outcome results
None listed