Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Recruiting
Phase 3
Interventional Study
Hyponatremia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults ( ≥18 years)
* Current admission in ICU
* Severe hyponatremia defined by SNa \<120 mmol/L in the presence of neurological symptoms (seizures, stupor defined as Glasgow score \< 12, or signs of brain herniation) or by SNa \<115 mmol/L
* Normal or decreased extracellular …
Contacts