Hyponatremia
Conditions
Interventions
Product Name: UREA
Pharmaceutical Form: Oral solution
INN or Proposed INN: UREA
CAS Number: 57-13-6
Concentration unit: g gram(s)
Concentration type: range
Concentration number: 40-100
Pharmaceutical
Sponsors
CHU Grenoble-Alpes
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: - Severe cardiac decompensation (LVEF 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the effectiveness of urea therapy in correcting a persistent hyponatremia despite adequate management during an subarachnoid hemorrhage;Secondary Objective: 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;Primary end point(s): Variation of the sodium concentration in mmol / L measured before introduction of the treatment and the day of treatment discontinuation;Timepoint(s) of evaluation of this end point: 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
France
Contacts
Public ContactDRCI
CHU Grenoble-Alpes
Outcome results
None listed