Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06020495

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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