Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT06020495
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06020495
Study Brief:
Protocol Section:
NCT06020495