DASSOH - Systematic use of DDAVP to prevent serum sodium overcorrection in severe hyponatremia : a multicenter open-label randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 9
- 主要终点
- Proportion of patients with SNa level overcorrection at any time during the first 48h after randomization.
研究概览
简要总结
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).
研究设计
- 分配方式
- Randomized
- 主要目的
- Multicenter Open-label Randomized Controlled Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion of patients with SNa level overcorrection at any time during the first 48h after randomization.
Proportion of patients with SNa level overcorrection at any time during the first 48h after randomization.
SNa overcorrection is defined according to presence or absence of risk factors at the time of randomization (chronic alcohol abuse, malnutrition, thiazides or antidepressant medicines, serum potassium<3.0mmol/L, glycaemia>20mmol/L) for CPM: • Patients with any risk factor: SNa increase>6.0 mmol/L in less than 24h, or a SNa increase>12.0 mmol/L in less than 48h. • Patients without risk factor: SNa increase>10.0mmol/L in less than 24h, or a SNa increase>18.0 mmol/L in less than 48h.
SNa overcorrection is defined according to presence or absence of risk factors at the time of randomization (chronic alcohol abuse, malnutrition, thiazides or antidepressant medicines, serum potassium<3.0mmol/L, glycaemia>20mmol/L) for CPM: • Patients with any risk factor: SNa increase>6.0 mmol/L in less than 24h, or a SNa increase>12.0 mmol/L in less than 48h. • Patients without risk factor: SNa increase>10.0mmol/L in less than 24h, or a SNa increase>18.0 mmol/L in less than 48h.
次要结局
- Proportion of patients with neurological symptoms at inclusion and who subsequently have a normal Glasgow Coma Scale at H6
- Length of ICU and hospital stay
- Time to death after inclusion
- Proportion of patients with the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria at day 15 (or earlier if clinically justified)
- Proportion of patients with any (pontine or extrapontine), symptomatic or not, osmotic demyelination as assessed by brain MRI at day 15 (or earlier if clinically justified)
- Proportion of patients with neurological symptoms with an increase of 5.0 mmol/L or more of SNa from inclusion to H6
- Urine output between (i) H0 and H6, (ii) H6 and H12, (iii) H12 and H24, and (iv) H24 and H48
- Urine osmolality between (i) H0 and H6, (ii) H6 and H12, (iii) H12 and H24, and (iv) H24 and H48
- Slope of the SNa increase between (i) H0 and H24 and (ii) H0 and H48
- Maximum change of SNa from baseline between (i) H0 and H24 and (ii) H0 and H48
- Total amount of intravenous hypotonic fluids administered between (i) H0 and H24 and (ii) H24 and H48
- Total amount of sodium and potassium administered between (i) H0 and H24 and (ii) H24 and H48
- Proportion of patients with seizures, stupor or sign of brain herniation appearing or reappearing after inclusion
- Occurrence of a reduction of SNa of 5.0 mmol/L or more from inclusion between H0 and H48
研究者
Coordinating investigator : Pr Stéphane GAUDRY
Scientific
Assistance Publique Hopitaux De Paris