Using DDAVP to prevent sodium overcorrection in severe hyponatremia

Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial

This study is testing if adding a medication called DDAVP to standard treatment can help ICU patients with severe low sodium levels avoid dangerous complications from rapid sodium changes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 12 sites (Amiens and 11 other locations)
• Trial ID: NCT06020495 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are currently admitted to the ICU with severe hyponatremia and neurological symptoms.

Not a fit: Patients with conditions causing increased extracellular fluid volume or those with contraindications to DDAVP will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of complications associated with rapid sodium overcorrection in critically ill patients.

How similar studies have performed: While the use of DDAVP in this context is innovative, similar studies have not been widely reported, indicating this approach may be novel.

Eligibility criteria

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)

Where this trial is running

Amiens and 11 other locations

• 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)

Study contacts

• Study coordinator: GAUDRY Stéphane

Conditions Hyponatremia