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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called DDAVP to help prevent a dangerous condition called serum sodium overcorrection in patients with severe hyponatremia. Hyponatremia is when the sodium level in the blood is too low, which can lead to serious health issues, especially in patients who are critically ill in the Intensive Care Unit (ICU). The trial is looking for adults aged 18 and older who are currently in the ICU, have severe hyponatremia (with sodium levels below 120 mmol/L) along with neurological symptoms, and have normal or reduced fluid levels in their body.

If someone qualifies for this trial, they will be treated with DDAVP to see if it helps safely manage their sodium levels without causing rapid changes that could be harmful. However, there are specific criteria that could prevent a patient from participating, such as having certain medical conditions like severe kidney disease or heart issues, or if they have had recent surgeries. It's important for potential participants to discuss with their healthcare team whether this trial is a good option for them.

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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)