Informations générales (source: ClinicalTrials.gov)
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2024
novembre 2026
14 septembre 2025
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE ST-DENIS | GAUDRY Stéphane | 18/09/2025 17:34:23 | Contacter | ||
| CENTRE HOSPITALIER SUD FRANCILIEN | GAUDRY Stéphane | 18/09/2025 17:34:23 | Contacter | ||
| CH DES DEUX VALLEES SITE LONGJUMEAU | GAUDRY Stéphane | 18/09/2025 17:34:23 | Contacter | ||
| HOPITAL FOCH | Benjamin Zuber | 18/09/2025 18:00:36 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:34:23 | Contacter | |||
| AP-HP - Hôpital Avicenne | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Jean Verdier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Louis Mourier | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:34:23 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:34:23 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:34:23 | Contact (sur clinicalTrials) | ||||
| Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien - 91100 - Corbeil-Essonnes - France | Guillaume CHEVREL | 18/09/2025 17:34:23 | Contact (sur clinicalTrials) | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie - 80054 - Amiens - France | Julien MAIZEL | Contact (sur clinicalTrials) | |||
| Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière - 75013 - Paris - France | Julien MAYAUX | Contact (sur clinicalTrials) | |||
| Médecine Intensive et Réanimation - Hôpital François Mitterand - 21079 - Dijon - France | Jean-Pierre QUENOT | Contact (sur clinicalTrials) | |||
| Médecine Intensive Réanimation - Hôpital Delafontaine - 93200 - Saint-Denis - France | Daniel DA SILVA | Contact (sur clinicalTrials) | |||
| Réanimation Médicale - Hôpital de Longjumeau - 91160 - Longjumeau - France | Matthieu LE MEUR | Contact (sur clinicalTrials) | |||
| Réanimation Polyvalente - Centre Hospitalier Départemental Vendée - 85000 - La Roche-sur-Yon - France | Laurent MARTIN LEFEVRE | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestive
heart failure, nephrotic syndrome);
- Hyponatremia caused by hyperglycaemia (> 30 mmol/L) or hypertriglyceridemia (10 g/L)
or hyperproteinaemia (120 g/L)
- Severe acute kidney injury (KDIGO 3)
- Severe chronic kidney disease (eGFR <20 ml/min)
- Coronary patients well stabilized with trinitrine-based medicines
- Recent neurosurgery or traumatic brain injury
- 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 IIB
- Severe previous neurologic disability (Glasgow Outcome Scale: GOS < 3)
- Diabetes insipidus receiving DDAVP treatment
- Moribund state (patient likely to die within 24h)
- Need for invasive mechanic ventilation
- Enrolment to another interventional study (clinical trial on medicinal product,
medical device and interventional research involving human participants not
concerning health product)
- 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)