Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia

NCT06020495 | Recruiting Phase 3

• 1 other identifier: APHP220676
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 12

Brief Summary

ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

• reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after 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

  48 hours after the randomization

Secondary Outcomes (24)

• the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion

  6 hours after the randomization

• ICU and hospital length of stay

  ICU or hospital discharge

• survival

  death after randomization

• the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria

  15 days after randomization

• the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI

  15 days after randomization

Study Arms (2)

DDAVP

EXPERIMENTAL

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

Drug: DDAVP

Standard hyponatremia treatment

ACTIVE COMPARATOR

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

Drug: Standard hyponatremia treatment

Interventions

DDAVP DRUG

Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h)

DDAVP

Standard hyponatremia treatment DRUG

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

Standard hyponatremia treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (12)

Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie

Amiens, 80054, France

RECRUITING

Médecine Intensive et Réanimation - Hôpital Avicenne

Bobigny, 93000, France

RECRUITING

Réanimation Polyvalente - Hôpital Jean Verdier

Bondy, France

RECRUITING

Médecine Intensive et Réanimation - Hôpital Louis Mourier

Colombes, 92700, France

RECRUITING

Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

NOT YET RECRUITING

Médecine Intensive et Réanimation - Hôpital Henri Mondor

Créteil, 94000, France

RECRUITING

Médecine Intensive et Réanimation - Hôpital François Mitterand

Dijon, 21079, France

NOT YET RECRUITING

Réanimation Polyvalente - Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000, France

RECRUITING

Réanimation Médicale - Hôpital de Longjumeau

Longjumeau, 91160, France

NOT YET RECRUITING

Médecine Intensive et Réanimation - Hôpital de la Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Médecine Intensive Réanimation - Hôpital Delafontaine

Saint-Denis, 93200, France

RECRUITING

Réanimation Polyvalente - Hôpital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Hyponatremia

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

GAUDRY Stéphane

CONTACT

01.48.95.55.55; stephane.gaudry@aphp.fr

DECHANET Aline

CONTACT

01 40 25 78 30; aline.dechanet@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: August 31, 2023
• Study Start: December 17, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)