Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyponatremia Subarachnoid Hemorrhage SIADH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparative study in 2 parallel arms, monocentric, randomized, double blind.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EXPERIMENTAL GROUP

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)

Group Type EXPERIMENTAL

Urea

Intervention Type DRUG

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.

CONTROL GROUP

the control group will be treated during 5 days by ergytonyl dose per administration : 5mL

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type OTHER

the control group will be treated during 5 days by ergytonyl dose per administration : 5mL

Interventions

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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.

Intervention Type DRUG

PLACEBO

the control group will be treated during 5 days by ergytonyl dose per administration : 5mL

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No