E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
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 |
Demonstrate the effectiveness of urea therapy in correcting a
persistent hyponatremia despite adequate management
during an subarachnoid hemorrhage |
|
E.2.2 | Secondary objectives of the trial |
1. Compare the sodium intake needed to correct the
natremia
2. Study the mechanism of action of urea
3. Evaluate the impact of the treatment on the length of stay
4. Assess the impact of treatment on neurological fate at 3
inclusion month
5. Assess the side effects of the treatment
6. Persistence of the 48 hours sodium correction after stopping the
treatment
7. Comparison of the speed of correction of the blood sodium level |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients at least 18 years old
- Non-traumatic subarachnoid hemorrhage
- Hyponatremia defined by a serum lower than 135
mmol / L and high natriuresis, greater than 250 mmol / L
despite well-conducted salt additions |
|
E.4 | Principal exclusion criteria |
- Severe cardiac decompensation (LVEF <30%)
- Severe hepatic cirrhosis (PT <30%, ascites), insufficiency
known severe renal (GFR <30mL / min / 1.73m²)
- Blood urea> 25 mmol / L in the basal state
- Osmotherapy and diuretics in the last 48 hours
- Ongoing treatment with systemic corticosteroids
- All protected persons: woman pregnant, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person making subject to legal protection.
- Patient not affiliated to a social security scheme
- Known hypersensitivity to any of the components of energytonyl
- Contraindications to energytonyl: taking anticoagulants,
diabetic patients treated |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Variation of the sodium concentration in mmol / L measured before introduction of the treatment and the day of treatment discontinuation |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Measurement of daily sodium intake in each group
2. Daily plasma levels of co-peptin in each group
during treatment and 48 hours after stopping treatment.
3. Duration of resuscitation and / or continuing care unit stay
4. Measurement of the modified Rankin score at 3 months
5. Prevalence of adverse effects of urea (headache,
digestive disorders…)
6. Variation of the mmol / L serum measured before introduction
of treatment and 48 hours after stopping treatment
7. Average time to correct blood sugar level to reach Na>
135 mmol / L after start of treatment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 1 |
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
|
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |