Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial

APHP220676

ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.

2024-01-01

2026-01-31

2026-03-31

Not yet recruiting

Early phase I

260

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 fluid volume Exclusion Criteria: * Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive heart failure, nephrotic syndrome); * Previous DDAVP or hypertonic fluid administration for the current episode of severe hyponatremia * SNa increased by 5 mmol or more between admission at hospital and randomisation (H0) * Known contraindication to DDAVP * Allergy * Syndrome of inappropriate antidiuretic hormone secretion (SIADH) * History of unstable angina and/or known or suspected heart failure. * Willebrand disease type 2b (due to risk of thrombocytopenia) * Severe previous neurologic disability (Glasgow Outcome Scale \< 3) * Diabetes insipidus receiving DDAVP treatment * Moribund state (patient likely to die within 24h) * Need for invasive mechanic ventilation * Limitation of life support (comfort care applied only) at the time of screening * Enrolment to another interventional study on hyponatremia care/management * Pregnancy or breastfeeding * Subject deprived of freedom, subject under a legal protective measure * No affiliation to any health insurance system * Refusal to participate to the study (patient or legal representative or family member or close relative if present)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium \\< 3.0 mmol/L).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 260, 'type': 'ESTIMATED'}}

2023-08-31