E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with postoperative delirium in the termination phase of anaesthesia after ACVB or aortic valve/mitral valve surgery or double heart intervention (heart-lung-machine (HLM) and mild hypothermia) |
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E.1.1.1 | Medical condition in easily understood language |
Delirant state on arousal from heart surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012218 |
E.1.2 | Term | Delirium |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
Investigation of efficacy of physostigminsalicylate on the basis of the Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU) 30 minutes after administration of the IMP
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E.2.2 | Secondary objectives of the trial |
Investigation of efficacy and tolerability of physostigminsalicylate on the basis of the following parameters:
Result of the Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU) 120 minutes after administration of the IMP
Plasma activity of acetylcholinesterase (AChE) 60 minutes after administration of the IMP
Result of the Richmond Agitation and Sedation Scales Test (RASS) 30 and 120 minutes after administration of the IMP
Adverse Events up to 120 minutes after administration of the IMP
Vital parameters (blood pressure, heart rate, fillings pressures and blood oxygen saturation) documented 10, 20, 30, 60 and 120 minutes after administration of the IMP |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed Consent),
2. Indication for an elective ACVB or a aortic valve surgery or mitral valve surgery or double heart intervention under use of HLM with mild hypothermia,
3. 18 ≤ age < 90,
4. Negative pregnancy test in women with childbearing potential,
5. Ability to understand the meaning of the study.
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E.4 | Principal exclusion criteria |
1. Known neurological deficite,
2. Known asthma bronchiale
3. Acute bleeding,
4. Acute renal insufficiency,
5. Use of a ciruculation support system,
6. Body weight >130 kg,
7. Concurrent participation in another interventional clinical trial,
8. Concomittant therapy for cerebral impairment and cerebral circulatory disorders,
9. Known intolerance / hypersensitivity to the IMPs or other compounds with similar chemical structure. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Confusion Assessment Method for the Intensive Care Unit Test (CAM-ICU) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes after administration of the IMP |
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E.5.2 | Secondary end point(s) |
Richmond Agitation and Sedation Scales
Plasma activity of AChE and plasma levels of IL-6 and TNFalpha
Adverse Events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 and 120 minutes after administration of the IMP
60 minutes after administration of the IMP
Up to 120 minutes after administration of the IMP |
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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 | 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) | Yes |
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 | 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 | 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 | 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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End of the trial: End of the follow-up of the last subject |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |