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DASSOH - Systematic use of DDAVP to prevent serum sodium overcorrection in severe hyponatremia : a multicenter open-label randomized controlled trial
EU CTIS ID: 2023-507254-32-00
What this study is testing
To determine whether the systematic DDAVP administration decreases the occurrence of serum sodium concentration (SNa) overcorrection during the first 48 hours after randomization in patients with severe hyponatremia (SNa < 115 mmol/L or < 120mmol/L in patients with neurological symptoms).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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, confusion defined as GCS ≤ 14, or signs of brain herniation) or by SNa < 115 mmol/L
- 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)
- 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
- Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)
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, confusion defined as GCS ≤ 14, 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)
- 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
- 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)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.