Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

  • STATUS
    Recruiting
  • End date
    Jan 8, 2023
  • participants needed
    52
  • sponsor
    University Hospital, Grenoble
Updated on 8 May 2021

Summary

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.

Details
Condition Pituitary Disease, SIADH, Hyponatremia, Subarachnoid Hemorrhage, Low Blood Sodium (Hyponatremia), Pituitary Disorders
Treatment urea, Placebo
Clinical Study IdentifierNCT04552873
SponsorUniversity Hospital, Grenoble
Last Modified on8 May 2021

Eligibility

Yes No Not Sure

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 / 1.73m)
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
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