Ended Therapeutic exploratory (Phase II) hyponatremia during subarachnoid hemorrhage

Urea treatment of hyponatremia in subarachnoid hemorrhage

EU CTIS ID: 2024-518532-36-00

What this study is testing

Demonstrate the efficacy of urea therapy in correcting persistent hyponatremia despite adequate management (Appendix 2), during SAH.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients aged 18 and over
  • Non-traumatic SAH: Hyponatremia defined by a natraemia of less than 135 mmol/L and a high natriuresis, greater than 250 mmol/J despite well-managed salt intake.

You likely can't join if

  • Severe cardiac decompensation (LVEF < 30%)
  • Severe hepatic cirrhosis (PT < 30%, ascites), known severe renal insufficiency (GFR < 30mL/min/1.73m²)
  • Blood urea > 25 mmol/L in basal state
  • Osmotherapy and diuretics in the last 48 hours
  • Ongoing treatment with systemic corticosteroids
  • Persons covered by articles L1121-5 to L1121-8 of the CSP, corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons not subject to a legal protection measure.
See the full eligibility criteria
Who can join
  • Patients aged 18 and over
  • Non-traumatic SAH: Hyponatremia defined by a natraemia of less than 135 mmol/L and a high natriuresis, greater than 250 mmol/J despite well-managed salt intake.
What rules you out
  • Severe cardiac decompensation (LVEF < 30%)
  • Severe hepatic cirrhosis (PT < 30%, ascites), known severe renal insufficiency (GFR < 30mL/min/1.73m²)
  • Blood urea > 25 mmol/L in basal state
  • Osmotherapy and diuretics in the last 48 hours
  • Ongoing treatment with systemic corticosteroids
  • Persons covered by articles L1121-5 to L1121-8 of the CSP, corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons not subject to a legal protection measure.
  • Patient not affiliated to a social security scheme
  • Known hypersensitivity to any component of ergytonyl
  • Contraindications to ergytonyl: currently taking curative anticoagulants, previously known and treated diabetic patients

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.