E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Post-operative complications in patients who undergo major surgery |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
• 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
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference in 30 day post-operative morbidity between study groups |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 17 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
For the purposes of pharmacovigilance, the end of the trial will be defined as the end of the 30-day period of follow-up for the final participant in the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |