DRUG
DDAVP
Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Status
Recruiting
Phase
Phase 3
Enrollment
260
Locations
12
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Full 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 central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium \< 3.0 mmol/L). Patients in ICU with severe hyponatremia defined by SNa \< 115 mmol/L or SNa \< 120 mmol/L in the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score \<12 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included. After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score \<12 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse \[defined according to World Health Organization definition\], malnutrition \[BMI\<20.5 or weight loss \>5% in 3 months\], serum potassium \< 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. However, all investigators will be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and analyzed blinded to the randomization group
Interventions
Treatment arms and agents.
DRUG
Standard hyponatremia treatment
Standard hyponatremia treatment alone : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
Timeline
From registration to results.
First posted
Aug 31, 2023
Study start
Dec 17, 2024
Primary completion
Sep 30, 2026
Study completion
Nov 30, 2026
Results posted
Not reported
Registry updated
May 23, 2025
Outcomes
What the study measures.
Primary outcomes
reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization
Time frame · 48 hours after the randomization
proportion of patients with SNa level overcorrection : any risk factor: SNa increase \> 6 mmol/L in less than H24, or \>12 mmol/L in less than H48. Without risk factor: SNa increase \> 10 mmol/L in less than H24, or \> 18 mmol/L in less than H48
Secondary outcomes
the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion
Time frame · 6 hours after the randomization
proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6
ICU and hospital length of stay
Time frame · ICU or hospital discharge
length of ICU and hospital stay
survival
Time frame · death after randomization
time to death after inclusion
the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria
Time frame · 15 days after randomization
proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)
the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI
Time frame · 15 days after randomization
proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 (or earlier if clinically justified)
on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level
Time frame · 6 hours after the randomization
proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6
the urine output between H0 and H6
Time frame · 6 hours after the randomization
urine output between H0 and H6
the urine output between H6 and H12
Time frame · 12 hours after the randomization
urine output between H6 and H12
the urine output between H12 and H24
Time frame · 24 hours after the randomization
urine output between H12 and H24
the urine output between H24 and H48
Time frame · 48 hours after the randomization
urine output between H24 and H48
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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)
Study locations
12 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
Amiens, France
Médecine Intensive et Réanimation - Hôpital Avicenne
Bobigny, France
Réanimation Polyvalente - Hôpital Jean Verdier
Bondy, France
Médecine Intensive et Réanimation - Hôpital Louis Mourier
Colombes, France
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
Médecine Intensive et Réanimation - Hôpital Henri Mondor
Créteil, France
Médecine Intensive et Réanimation - Hôpital François Mitterand
Dijon, France
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Réanimation Médicale - Hôpital de Longjumeau
Longjumeau, France
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
Paris, France
Médecine Intensive Réanimation - Hôpital Delafontaine
Saint-Denis, France
Réanimation Polyvalente - Hôpital Foch
Suresnes, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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