Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie
RECRUITING
Amiens
Médecine Intensive et Réanimation - Hôpital Avicenne
RECRUITING
Bobigny
Réanimation Polyvalente - Hôpital Jean Verdier
RECRUITING
Bondy
Médecine Intensive et Réanimation - Hôpital Louis Mourier
RECRUITING
Colombes
Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien
NOT_YET_RECRUITING
Corbeil-essonnes
Médecine Intensive et Réanimation - Hôpital Henri Mondor
RECRUITING
Créteil
Médecine Intensive et Réanimation - Hôpital François Mitterand
NOT_YET_RECRUITING
Dijon
Réanimation Polyvalente - Centre Hospitalier Départemental Vendée
RECRUITING
La Roche-sur-yon
Réanimation Médicale - Hôpital de Longjumeau
NOT_YET_RECRUITING
Longjumeau
Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière
RECRUITING
Paris
Médecine Intensive Réanimation - Hôpital Delafontaine
RECRUITING
Saint-denis
Réanimation Polyvalente - Hôpital Foch
RECRUITING
Suresnes
Contact Information
Primary
GAUDRY Stéphane
stephane.gaudry@aphp.fr
01.48.95.55.55
Backup
DECHANET Aline
aline.dechanet@aphp.fr
01 40 25 78 30
Time Frame
Start Date: 2024-12-17
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 260
Treatments
Experimental: DDAVP
DDAVP 4µg/ml IV Additional doses may be administrated every 6h for a maximum of 48h~\- Standard hyponatremia treatment : Presence of neurological symptoms : sodium chloride 3% 150ml for 20 min Absence of neurological symptoms : Hyper or isotonic fluid but never hypotonic
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris