Phase
Condition
Hyponatremia
Treatment
Standard hyponatremia treatment
DDAVP
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults ( ≥18 years)
Current admission in ICU
Severe hyponatremia defined by SNa <120 mmol/L in the presence of neurologicalsymptoms (seizures, stupor defined as Glasgow score < 12, or signs of brainherniation) or by SNa <115 mmol/L
Normal or decreased extracellular fluid volume
Exclusion
Exclusion Criteria:
Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestiveheart 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 severehyponatremia
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 notconcerning 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 familymember or close relative if present)
Study Design
Study Description
Connect with a study center
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, 80054
FranceSite Not Available
Médecine Intensive et Réanimation - Hôpital Avicenne
Bobigny, 93000
FranceSite Not Available
Médecine Intensive et Réanimation - Hôpital Louis Mourier
Colombes, 92700
FranceActive - Recruiting
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
FranceSite Not Available
Médecine Intensive et Réanimation - Hôpital Henri Mondor
Créteil, 94000
FranceSite Not Available
Médecine Intensive et Réanimation - Hôpital François Mitterand
Dijon, 21079
FranceSite Not Available
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85000
FranceSite Not Available
Réanimation Médicale - Hôpital de Longjumeau
Longjumeau, 91160
FranceSite Not Available
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, 75013
FranceSite Not Available
Réanimation Médico-Chirurgicale - Hôpital NOVO - Site de Pontoise
Pontoise, 95300
FranceSite Not Available
Médecine Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, 93200
FranceSite Not Available
Réanimation Polyvalente - Hôpital Foch
Suresnes, 92150
FranceSite Not Available
Réanimation et Surveillance continue - Centre Hospitalier Annecy Genevois
Épagny, 74370
FranceSite Not Available
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