Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage (NAT-URE)

Grenoble Alpes University Hospital Center (CHU)

Status: Active, not recruiting

Conditions: Subarachnoid Hemorrhage; Hyponatremia; SIADH

Treatments: Other: PLACEBO; Drug: Urea

Study type: Interventional

Funder types: Other

Identifiers

NCT04552873

38RC19.189

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

EXPERIMENTAL GROUP

Experimental group

Description:

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)

Treatment:

Drug: Urea

CONTROL GROUP

Placebo Comparator group

Description:

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

Treatment:

Other: PLACEBO