Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial (DASSOH)
Hyponatremia
About this trial
This is an interventional treatment trial for Hyponatremia
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 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
DDAVP
Standard hyponatremia treatment
DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h - Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
Standard hyponatremia treatment alone : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic