Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

• Register: ClinicalTrials.gov
• Last refreshed on: 24 February 2025
• Main ID: NCT04552873
• Date of registration: 10/09/2020
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Grenoble
• Public title: Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage NAT-URE
• Scientific title: Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage
• Date of first enrolment: December 3, 2020
• Target sample size: 52
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04552873
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Perrine BOUCHEIX, MD
• Affiliation: University Hospital, Grenoble

Key inclusion & exclusion 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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hyponatremia

Subarachnoid Hemorrhage

SIADH

Intervention(s)

Other: PLACEBO

Drug: Urea

Primary Outcome(s)

To demonstrate the effectiveness of urea therapy in correcting persistent hyponatremia despite adequate management during subarachnoid hemorrhage [Time Frame: 5 days]

Secondary Outcome(s)

To assess the impact of treatment on neurological outcome at 3 months from inclusion [Time Frame: 3 months]

To assess the adverse effects of treatment [Time Frame: 3 months]

To assess the impact of treatment on length of stay [Time Frame: 3 months]

To compare the sodium intake required to correct the natremia. [Time Frame: 8 days]

To study the mechanism of action of urea [Time Frame: 48 hours]

Persistence of correction of natraemia 48H after cessation of treatment [Time Frame: 48 hours after the end of treatment]

To compare the speed of correction of natraemia [Time Frame: 5 days]

Secondary ID(s)

38RC19.189

Source(s) of Monetary Support

Please refer to primary and secondary sponsors