Post-operative complications Injury, Occupational Diseases, Poisoning Complications of procedures, not elsewhere classified
Conditions
Interventions
Current interventions as of 03/05/2012
The trial intervention period begins at induction of anaesthesia and continues until six hours after surgery is complete (maximum duration 24 hou
Sponsors
Barts and The London School of Medicine and Dentistry, Queen Mary's University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients undergoing major abdominal surgery involving the gastrointestinal tract which is expected to take longer than 90 minutes are eligible for recruitment provided they satisfy one of the following additional criteria: 1. Urgent or emergency surgery 2. Acute or chronic renal impairment 3. Diabetes mellitus 4. Aged 65 years and older, either sex 5. Presence of a risk factor for cardiac or respiratory disease
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 03/05/2012 1. Patients receiving palliative treatment only 2. Acute myocardial ischaemia at time of enrolment 3. Pulmonary oedema at time of enrolment 4. Moderate/severe thromocytopenia (platelet count <50 x 109/l) 5. Patients receiving monoamine oxidase inhibitors (MAOIs) 6. Phaechromocytoma 7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis 8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate 9. Pregnancy 10. Septic shock Previous exclusion criteria 1. Patients receiving palliative treatment only 2. Acute myocardial ischaemia at time of enrolment 3. Pulmonary oedema at time of enrolment 4. Moderate/severe thromocytopenia 5. Patients receiving monoamine oxidase inhibitors (MAOIs) 6. Phaechromocytoma 7. Severe left ventricular outlet obstruction, e.g. hypertrophic obstructive cardiomyopathy or severe aortic stenosis 8. Known hypersensitivity to dopexamine hydrochloride or disodium edenate 9. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s): Difference in the number of patients developing post-operative complications or dying within 30 days following randomisation between study groups. Previous primary outcome measure(s): Difference in 28 days post-mortality between study groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure (s) as of 03/05/2012: 1. Difference in the number of patients developing 30-day post-operative mortality between groups 2. Difference in morbidity identified with the Post-Operative Morbidity Survey (POMS) for patients still in hospital on day seven after surgery 3. Difference in the number of patients developing infectious complications within 30 days of surgery 4. Difference in duration of post-operative hospital stay 5. Difference in 30 day critical care free days 6. Difference in 180 day post-operative mortality 7. Difference in cost effectiveness 8. Difference in healthcare costs Previous secondary outcome measure(s): 1. Difference in the number of patients developing post-operative complications within 28 days of surgery between groups 2. Difference in morbidity identified with the Post-Operative Morbidity Survey (POMS) for patients still in hospital on day seven after surgery 3. Difference in the number of patients developing infectious complications within 28 days of surgery 4. Difference in duration of post-operative hospital stay 5. Difference in 28 day critical care free days 6. Difference in 180 day post-operative mortality 7. Difference in cost effectiveness 8. Difference in healthcare costs | — |
Countries
United Kingdom
Outcome results
None listed