DASSOH - Systematic use of DDAVP to prevent serum sodium overcorrection in severe hyponatremia : a multicenter open-label randomized controlled trial

Phase 1

• Conditions: Severe hyponatremia and a high risk of rapid SNa overcorrection; MedDRA version: 22.1Level: LLTClassification code: 10054430Term: Hyponatremia aggravated Class: 10027433; MedDRA version: 20.1Level: LLTClassification code: 10021038Term: Hyponatremia Class: 10027433; MedDRA version: 26.0Level: LLTClassification code: 10070605Term: Rapid correction of hyponatremia Class: 10042613; Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

• Registration Number: CTIS2023-507254-32-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion 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 GCS < 12, or signs of brain herniation) or by SNa < 115 mmol/L, Normal or decreased extracellular fluid volume

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified