Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
University Hospital Grenoble
RECRUITING
Grenoble
Contact Information
Primary
Perrine BOUCHEIX, MD
pboucheix@chu-grenoble.fr
04 76 76 67 29
Backup
Anaïs ADOLLE
arcpar@chu-grenoble.fr
04 76 76 67 29
Time Frame
Start Date: 2020-12-03
Estimated Completion Date: 2024-12
Participants
Target number of participants: 52
Treatments
Experimental: 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)
Placebo_comparator: CONTROL GROUP
the control group will be treated during 5 days by ergytonyl dose per administration : 5mL
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov