Actively Recruiting
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-23
260
Participants Needed
12
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
CONDITIONS
Official Title
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (18 years or older)
- Current admission in ICU
- Severe hyponatremia defined by serum sodium below 120 mmol/L with neurological symptoms (seizures, stupor with Glasgow score below 12, or signs of brain herniation) or serum sodium below 115 mmol/L
- Normal or decreased extracellular fluid volume
You will not qualify if you...
- Obvious increase of extracellular fluid volume such as cirrhosis with ascites, congestive heart failure, or nephrotic syndrome
- Hyponatremia caused by hyperglycemia (> 30 mmol/L), hypertriglyceridemia (10 g/L), or hyperproteinemia (120 g/L)
- Severe acute kidney injury (KDIGO 3)
- Severe chronic kidney disease (eGFR below 20 ml/min)
- Stable coronary patients treated with trinitrine-based medicines
- Recent neurosurgery or traumatic brain injury
- Previous DDAVP or hypertonic fluid treatment for current severe hyponatremia episode
- Serum sodium increased by 5 mmol or more between hospital admission and randomization
- Known contraindications to DDAVP including allergy, SIADH, unstable angina or heart failure, Willebrand disease type IIB
- Severe previous neurological disability (Glasgow Outcome Scale below 3)
- Diabetes insipidus treated with DDAVP
- Moribund state with expected death within 24 hours
- Need for invasive mechanical ventilation
- Enrollment in another interventional clinical trial
- Pregnancy or breastfeeding
- Subject deprived of freedom or under legal protective measures
- No health insurance affiliation
- Refusal to participate by patient or legal representative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, France, 80054
Actively Recruiting
2
Médecine Intensive et Réanimation - Hôpital Avicenne
Bobigny, France, 93000
Actively Recruiting
3
Réanimation Polyvalente - Hôpital Jean Verdier
Bondy, France
Actively Recruiting
4
Médecine Intensive et Réanimation - Hôpital Louis Mourier
Colombes, France, 92700
Actively Recruiting
5
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Not Yet Recruiting
6
Médecine Intensive et Réanimation - Hôpital Henri Mondor
Créteil, France, 94000
Actively Recruiting
7
Médecine Intensive et Réanimation - Hôpital François Mitterand
Dijon, France, 21079
Not Yet Recruiting
8
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85000
Actively Recruiting
9
Réanimation Médicale - Hôpital de Longjumeau
Longjumeau, France, 91160
Not Yet Recruiting
10
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
11
Médecine Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, France, 93200
Actively Recruiting
12
Réanimation Polyvalente - Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
Research Team
G
GAUDRY Stéphane
CONTACT
D
DECHANET Aline
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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