Using DDAVP to prevent sodium overcorrection in severe hyponatremia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, prospective, open-label randomized controlled trial aimed at ICU patients suffering from severe hyponatremia, defined as serum sodium levels below 120 mmol/L, particularly in those with neurological symptoms. Patients will be randomly assigned to receive either standard treatment for hyponatremia or standard treatment plus DDAVP administered intravenously for 48 hours. The study will stratify participants based on the presence of neurological symptoms and risk factors for central pontine myelinolysis. The goal is to evaluate the effectiveness of DDAVP in preventing rapid sodium overcorrection, which can lead to serious complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ( ≥18 years)
* Current admission in ICU
* Severe hyponatremia defined by SNa \<120 mmol/L in the presence of neurological symptoms (seizures, confusion defined as Glasgow score \<= 14, 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)

Where it's running

• 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 Recruiting
• Médecine Intensive et Réanimation - Hôpital Henri Mondor
  Créteil, France Recruiting

Study contacts

• Study coordinator: GAUDRY Stéphane
• Email: stephane.gaudry@aphp.fr
• Phone: 01.48.95.55.55

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.