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 |
vasoplegic syndrome |
syndrome vasoplégique |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067654 |
E.1.2 | Term | Vasoplegic syndrome |
E.1.2 | System Organ Class | 100000004863 |
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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 determine the effect of dexchlorpheniramine (Polaramine®) compared to placebo (saline solution) on maintaining patient's hemodynamic stability after separation from cardiopulmonary bypass. |
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E.2.2 | Secondary objectives of the trial |
- Assessment of dexchlorpheniramine effects (Polaramine®) on patients presenting metabolic disease, a comorbidity known to increase the risk for vasoplegic syndrome during cardiac surgery under CBP (diabetes and/or chronic renal and/or liver insufficiency). - Comparison of the incidence of postoperative complications (renal failure, mesenteric ischemia, liver insufficiency) between the groups - Compare patients who received 10 mg of dexchlorpheniramine (Polaramine®) and those who received placebo, regarding the following data: o The length of hospital stay, o The amount of fluids delivered o The amount of catecholamine infused o Mortality at day 28 and at 6 months. - Assess patient's tolerance to Polaramine® in patients undergoing cardiac surgery requiring CBP.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men aged 18 and older Post menopausal women Patients scheduled for an aortic valve replacement with a traditional sternotomy and CBP |
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E.4 | Principal exclusion criteria |
- Patients with a left ventricular ejection fraction lower than 40%, - Patients with pulmonary arterial hypertension higher than 50mmHg, - Redo cardiac surgery, - Atrioventricular and intraventricular conduction disturbances - Atopic disease - Women of childbearing potential - Patients at risk of glaucoma - Patients with therapy interacting with dexchlorpheniramine (Polaramine®). - Patients unable to provide a signed informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
vasoplegic syndrom after surgery |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Blood histamine dosage 2. Immunophenotyping of basophil polynuclear cell 3. Pulmonary artery pressure 4. Creatinemia 5. Digestive ischemia 6. Vasoplegic syndrom after surgery for the subgroup 7. Hepatic insufficiency 8. Number of days of hospitalization and mortality
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 0 2. Day 0 3. Day 0 to day 2 4. Day 28 and 6 months 5. Day 28 and 6 months 6. Day 0 7. Day 28 and 6 months 8. Day 28 and 6 months |
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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 | No |
E.6.4 | Safety | No |
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 | 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
| 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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |