Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
Assistance Publique - Hôpitaux de Paris
260 participants
Dec 17, 2024
INTERVENTIONAL
Conditions
Summary
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Eligibility
Inclusion Criteria4
- 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 Criteria22
- 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)
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Interventions
Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)
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
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06020495