E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative (stress) hyperglycemia in patients with no known diabetes after acute abdominal surgery |
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E.1.1.1 | Medical condition in easily understood language |
elevated blood glucose after acute abdominal surgery in patients with no history of diabetes |
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E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 24.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042216 |
E.1.2 | Term | Stress induced hyperglycemia |
E.1.2 | System Organ Class | 100000004861 |
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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 investigate the safety and feasibility of treating postoperative hyperglycemia in patients with no history of diabetes after acute abdominal surgery. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital) - At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery - Age of 18 to 85 - Must be able to understand and sign informed content
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E.4 | Principal exclusion criteria |
- Patients diagnosed with diabetes mellitus - Impaired kidney function (eGFR < 45mL/min) - Severe liver disease (defined as transaminases above X 3 normal levels) - Acute pancreatitis within the last two months or a history of chronic pancreatitis - Participation in another pharmacological intervention trial - Predictable poor compliance (for instance mentally impaired) - Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) - Allergy to study medication
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is percentage of time in range (time with blood glucose level between 3.9 and 7.8mmol/l) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Study medication must be started within 48 hours after surgery. The endpoint is monitored for 10 days after starting the medication or until discharged, whichever comes first. |
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E.5.2 | Secondary end point(s) |
1) variability of blood glucose, mean blood glucose and time with hyper/hypo glycemia 2) quality of recovery-15 questionnaire 3) immunological changes (stress response) after surgery |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) monitored for 10 days after starting the medication or until discharged, whichever comes first. 2) every day while hospitalised up til 10 days of treatment 3) blood samples drawn at inclusion, on day four of treatment and when finishing treatment |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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30 days after surgery - the patients will receive a phone call and be asked to fill out a questionnaire |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |