E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
post-operative restoration of vigilance and cognition after cardiopulmonary bypass surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066123 |
E.1.2 | Term | Cardiopulmonary bypass |
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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 |
Improvement of the post-operative vigilance and cognitive functions after cardiosurgeries. |
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E.2.2 | Secondary objectives of the trial |
Reduction of the systemic inflammatory response after cardiosurgeries with extra-corporal circulation which is to be quantified by the examination of the pro-inflam¬ma¬¬tory and anti-inflammatory genes of immunocompetent cells in the serum (microarray).
CRP, procalcitonin, body temperature SIRS criteria Blood count (leucocytes, platelets, Hb content) Hemodynamic parameters (heart rate, blood pressure, probably cardiac output) ScvO2 Catecholamine demand Bilirubin, creatine, ASAT, gamma-GT Blood gases Quantification of the post-operative analgesic demand Quantification of pain intensity Quantification of post-operative nausea Acquisition of health-related quality of life (SF36)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Elective cardiosurgery (bypass surgery / prosthetic heart valve or reconstruction of the heat valve) - ASA classification II and III - Being of legal age - Written informed consent to participate in the clinical trial
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E.4 | Principal exclusion criteria |
1. Known contraindication to physostigmine salicylate, such as bronchial asthma or hypersensitivity to sulfites 2. Stenoses of the intestinal tract and the bile ducts 3. Pregnancy 4. Neurological diseases 5. Left ventricular ejection fraction < 40 % 6. Simultaneous participation in other clinical trials or participation in other clinical trials within the last 30 days.
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of the post-operative vigilance and cognitive functions |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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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last interview 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 | 2 |
E.8.9.1 | In the Member State concerned days | |