RecruitingPhase 3NCT06020495

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

260 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

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

DRUGDDAVP

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

DRUGStandard 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


Locations(12)

Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

Amiens, France

Médecine Intensive et Réanimation - Hôpital Avicenne

Bobigny, France

Réanimation Polyvalente - Hôpital Jean Verdier

Bondy, France

Médecine Intensive et Réanimation - Hôpital Louis Mourier

Colombes, France

Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Médecine Intensive et Réanimation - Hôpital Henri Mondor

Créteil, France

Médecine Intensive et Réanimation - Hôpital François Mitterand

Dijon, France

Réanimation Polyvalente - Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Réanimation Médicale - Hôpital de Longjumeau

Longjumeau, France

Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière

Paris, France

Médecine Intensive Réanimation - Hôpital Delafontaine

Saint-Denis, France

Réanimation Polyvalente - Hôpital Foch

Suresnes, France

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NCT06020495


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