Clinical trial

Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

Name
38RC19.189
Description
Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.
Trial arms
Trial start
2020-12-03
Estimated PCD
2024-06-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Urea
the experimental group will be treated during 5 days by urea dose per administration : 1g / kg / 24 hours in 2 or 3 doses morning, noon and evening (dose adjustment of urea according to weight) If hyponatremia persists beyond D8 after initiation of the study treatment (urea or placebo), that is to say after the date of the collection of the primary endpoint, it will be possible to introduce corticosteroids (fludrocortisone or others). These treatments will be collated. If during patient monitoring the serum sodium exceeds 145 mmol / L, treatment should no longer be administered.
Arms:
EXPERIMENTAL GROUP
PLACEBO
the control group will be treated during 5 days by ergytonyl dose per administration : 5mL
Arms:
CONTROL GROUP
Size
52
Primary endpoint
To demonstrate the effectiveness of urea therapy in correcting persistent hyponatremia despite adequate management during subarachnoid hemorrhage
5 DAYS
Eligibility criteria
Inclusion Criteria: * Patients aged at least 18 years old * Non-traumatic HSA * Hyponatremia defined by a natremia less than 135 mmol / L and a high natriuresis, greater than 250 mmol / L despite well-managed saline intakes Exclusion Criteria: * Severe cardiac decompensation (LVEF \<30%) * Severe hepatic cirrhosis (PT \<30%, ascites), known severe renal failure (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 * Persons referred to in Articles L1121-5 to L1121-8 of the CSP corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure. * Patient not affiliated to a social security scheme * Known hypersensitivity to any of the components of ergytonyl * Contraindications to ergytonyl: taking curative anticoagulants, previously known and treated diabetic patients
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparative study in 2 parallel arms, monocentric, randomized, double blind.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2023-12-11

1 organization

1 product

3 indications

Product
Urea
Indication
Hyponatremia
Indication
SIADH