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New treatment option for Hyponatremia
Official title Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
ClinicalTrials.gov ID: NCT06020495
What this study is testing
What is DDAVP?
DDAVP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hyponatremia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Normal or decreased extracellular fluid volume
You likely can't join 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
See the full eligibility 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
- 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 treatment study (clinical trial on medicinal product, medical device and treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bobigny, France
- Bondy, France
- Colombes, France
- Corbeil-Essonnes, France
- Créteil, France
- Dijon, France
- La Roche-sur-Yon, France
- Longjumeau, France
- Paris, France
- Saint-Denis, France
- Suresnes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bobigny, France; Bondy, France; Colombes, France; Corbeil-Essonnes, France; Créteil, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.