E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on developing cardiovascular complications and death of all causes at 30 days and one year after non-cardiac surgery in diabetics. |
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E.2.2 | Secondary objectives of the trial |
-To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on infectious complications, number of days in intensive care and hospital, severe haemorrhage, and venous thrombosis at 30 days and one year after non-cardiac surgery in diabetics. -To study the effect of intensive blood glucose control intraoperatively and 24 hours postoperatively on coagulation and inflammatory factor levels, and the change in coagulation and inflammatory factor levels during non-cardiac surgery in different groups of diabetic patients. -To study the role of inflammation and coagulation on developing cardiovascular, infectious, haemorrhagic and thrombotic complications at 30 days and one year after non-cardiac surgery in diabetics
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with type 1 or type 2 diabetes undergoing elective non-cardiac surgery. Patients are either treated with oral hypoglycaemic agents, insulin or diet-restrictions. - Age over 18 years - male or female - Able and willing to give informed consent |
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E.4 | Principal exclusion criteria |
Patients scheduled for surgery in day-care or emergency surgery - Psychiatric or mentally challenged patients (or patients with other disorders who will have difficulty filling out the questionnaires) - Patients with severe liver disease: Criteria: Child Pugh B or C, or bilirubinuria, elevation of serum bilirubin (>35 mmol/L), elevated aminotransferase levels (>500 U/L), elevated alkaline phosphatase (>4 times normal values), albumin < 28, INR > 1.7 - Patients who do not speak Dutch or English - Patients who are planned to be admitted postoperatively to the Intensive Care Unit (ICU) since in all ICUs a protocol on intensive glycaemic control is employed.
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study endpoints will be cardiovascular complications and death from all causes at 30 days and 1 year after non-cardiac surgery, comparing patients with diabetes mellitus undergoing conventional or intensive perioperative blood glucose control. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
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
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last visit of last subject is defined as end of trial.
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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 | |
E.8.9.1 | In the Member State concerned days | |