E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 |
Knowing that critically ill patients who need to be on ventilators are at high risk of delirium , does giving them simvastatin decrease the length of time they are delirious for? |
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E.2.2 | Secondary objectives of the trial |
The secondary aims of this study are 1) to examine other important clinical outcomes i.e.the number of patients who become delirious, how many die, how long they are in hospital for, brain function at 6 months, quality of life after discharge, safety and cost-effectiveness 2) to assess the potential of plasma beta amyloid 42/40 levels as a predictor of the risk of developing cognitive impairment after an episode of delirium. 3) see if statins decrease inflammation associated with delirium by a series of blood tests looking for substances that increase when a patient has general inflammation. 4) look for evidence of changes in the brain chemistry in patients who have delirium - low cholinergic levels - by looking for levels of the same substance in the blood. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients requiring mechanical ventilation within 72 hours of admission to intensive care. |
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E.4 | Principal exclusion criteria |
Age less than 18 years Patient known to be pregnant Known allergy to statin drugs CK > 10 times upper limit of normal range Alanine aminotransferase (ALT) >8 times the upper limit of normal range Patients currently receiving ongoing and sustained treatment with any of the following; itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, cyclosporine, amiodarone, verapamil or diltiazem Uncomplicated elective surgery Patient expected to be discharged within 48 hours of admission Patients with severe renal impairment (estimated creatinine clearance less than 15ml/minute) not receiving renal replacement therapy Severe liver disease Current or recent treatment (within 2 weeks) with statins Physician decision that a statin is required for proven indication Contraindication to enteral drug administration, e.g. patients with mechanical bowel obstruction. Patients with high gastric aspirates due to an ileus are not excluded. Known participation in investigational medicinal product (IMP) trials within 30 days Consent declined Treatment withdrawal likely within 48 hours Non−English speaking patients or those who do not adequately understand verbal or written information.
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E.5 End points |
E.5.1 | Primary end point(s) |
Delirium/coma free days at 14 days. |
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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 | Yes |
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) | 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
| Yes |
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 | 1 |
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 | No |
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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Six months after the last patient recruited has been discharged from the hospital. |
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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 | 9 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |