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

Last updated: December 19, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

3

Condition

Hyponatremia

Treatment

Standard hyponatremia treatment

DDAVP

Clinical Study ID

NCT06020495
APHP220676
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults ( ≥18 years)

  • Current admission in ICU

  • Severe hyponatremia defined by SNa <120 mmol/L in the presence of neurologicalsymptoms (seizures, stupor defined as Glasgow score < 12, or signs of brainherniation) or by SNa <115 mmol/L

  • Normal or decreased extracellular fluid volume

Exclusion

Exclusion Criteria:

  • Obvious increase of extracellular fluid volume (cirrhosis with ascites, congestiveheart 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 severehyponatremia

  • 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 notconcerning 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 familymember or close relative if present)

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: Standard hyponatremia treatment
Phase: 3
Study Start date:
December 17, 2024
Estimated Completion Date:
November 30, 2026

Study Description

Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L).

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

Connect with a study center

  • Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

    Amiens, 80054
    France

    Site Not Available

  • Médecine Intensive et Réanimation - Hôpital Avicenne

    Bobigny, 93000
    France

    Site Not Available

  • Médecine Intensive et Réanimation - Hôpital Louis Mourier

    Colombes, 92700
    France

    Active - Recruiting

  • Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • Médecine Intensive et Réanimation - Hôpital Henri Mondor

    Créteil, 94000
    France

    Site Not Available

  • Médecine Intensive et Réanimation - Hôpital François Mitterand

    Dijon, 21079
    France

    Site Not Available

  • Réanimation Polyvalente - Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85000
    France

    Site Not Available

  • Réanimation Médicale - Hôpital de Longjumeau

    Longjumeau, 91160
    France

    Site Not Available

  • Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière

    Paris, 75013
    France

    Site Not Available

  • Réanimation Médico-Chirurgicale - Hôpital NOVO - Site de Pontoise

    Pontoise, 95300
    France

    Site Not Available

  • Médecine Intensive Réanimation - Hôpital Delafontaine

    Saint-Denis, 93200
    France

    Site Not Available

  • Réanimation Polyvalente - Hôpital Foch

    Suresnes, 92150
    France

    Site Not Available

  • Réanimation et Surveillance continue - Centre Hospitalier Annecy Genevois

    Épagny, 74370
    France

    Site Not Available

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