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Recruiting Phase 3

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

NCT06020495 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2024-12-17
Last updated
2025-05-23

Condition(s) studied

Hyponatremia

Investigational drug(s) / intervention(s)

DDAVP →Standard hyponatremia treatment

DDAVP: Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)

Standard hyponatremia treatment: 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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * 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)

Primary outcome measure(s)

  • reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization — 48 hours after the randomization
    proportion of patients with SNa level overcorrection : any risk factor: SNa increase \> 6 mmol/L in less than H24, or \>12 mmol/L in less than H48. Without risk factor: SNa increase \> 10 mmol/L in less than H24, or \> 18 mmol/L in less than H48

Trial sites (12)

FacilityCityRegionStatus
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie Amiens France Recruiting
Médecine Intensive et Réanimation - Hôpital Avicenne Bobigny France Recruiting
Réanimation Polyvalente - Hôpital Jean Verdier Bondy France Recruiting
Médecine Intensive et Réanimation - Hôpital Louis Mourier Colombes France Recruiting
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien Corbeil-Essonnes France Not Yet Recruiting
Médecine Intensive et Réanimation - Hôpital Henri Mondor Créteil France Recruiting
Médecine Intensive et Réanimation - Hôpital François Mitterand Dijon France Not Yet Recruiting
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée La Roche-sur-Yon France Recruiting
Réanimation Médicale - Hôpital de Longjumeau Longjumeau France Not Yet Recruiting
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière Paris France Recruiting
Médecine Intensive Réanimation - Hôpital Delafontaine Saint-Denis France Recruiting
Réanimation Polyvalente - Hôpital Foch Suresnes France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06020495 on ClinicalTrials.gov ↗ ← All trials in France