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Recruiting Phase 3 NCT06020495

Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia

Trial Parameters

Condition Hyponatremia
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 260
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-17
Completion 2026-09-30
Interventions
DDAVPStandard hyponatremia treatment

Brief Summary

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

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); * 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 *

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