Status:
RECRUITING
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hyponatremia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06020495
Start Date
December 17 2024
End Date
November 30 2026
Last Update
May 23 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, France, 80054
2
Médecine Intensive et Réanimation - Hôpital Avicenne
Bobigny, France, 93000
3
Réanimation Polyvalente - Hôpital Jean Verdier
Bondy, France
4
Médecine Intensive et Réanimation - Hôpital Louis Mourier
Colombes, France, 92700