rea treatment of hyponatremia during subarachnoid hemorrhage

Phase 1

• Conditions: Hyponatremia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-001084-83-FR
• Lead Sponsor: CHU Grenoble-Alpes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-10
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified