Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
NCT ID: NCT06020495
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
260 participants
INTERVENTIONAL
2024-12-17
2026-11-30
Brief Summary
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Detailed Description
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Patients in ICU with severe hyponatremia defined by SNa \< 115 mmol/L or SNa \< 120 mmol/L in the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score \<12 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included.
After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score \<12 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse \[defined according to World Health Organization definition\], malnutrition \[BMI\<20.5 or weight loss \>5% in 3 months\], serum potassium \< 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. However, all investigators will be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and analyzed blinded to the randomization group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DDAVP
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Khalil CHAIBI, MD
Role: primary
Other Identifiers
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APHP220676
Identifier Type: -
Identifier Source: org_study_id
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