Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: DDAVP, Standard hyponatremia treatment.
- Кому может быть актуально
- Состояния в реестре: Hyponatremia. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia: a Multicenter Open-label Randomized Controlled Trial
Обзор
ICU patients with severe hyponatremia and a high risk of rapid SNa overcorrection.
Подробное описание
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).
Patients in ICU with severe hyponatremia defined by SNa \< 115 mmol/L or SNa \< 120 mmol/L in the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score \<12 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included.
After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score \<12 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse \[defined according to World Health Organization definition\], malnutrition \[BMI\<20.5 or weight loss \>5% in 3 months\], serum potassium \< 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. However, all investigators will be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and analyzed blinded to the randomization group
Вмешательства
- Препарат DDAVP
Posology: 4µg in 2ml IV solution Route of administration: Intravenous Duration of treatment: 48h maximum (additional doses every 6h) - Препарат Standard hyponatremia treatment
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
Первичные конечные точки
- reduced occurrence of overcorrection of serum sodium concentration (SNa) in the first 48 hours after randomization [Срок оценки: 48 hours after the randomization]
Вторичные конечные точки (12)
- the reversal of acute neurological symptoms in patients with neurological symptoms at inclusion [Срок оценки: 6 hours after the randomization]
- ICU and hospital length of stay [Срок оценки: ICU or hospital discharge]
- survival [Срок оценки: death after randomization]
- the occurrence of central pontine myelinolysis diagnosed on clinical and MRI criteria [Срок оценки: 15 days after randomization]
- the occurrence of any (pontine or extrapontine) osmotic demyelination as assessed by brain MRI [Срок оценки: 15 days after randomization]
- on the percentage of patients with neurological symptoms at inclusion and reaching the initial goal of rapid partial pre-defined correction of SNa level [Срок оценки: 6 hours after the randomization]
- the urine output between H0 and H6 [Срок оценки: 6 hours after the randomization]
- the urine output between H6 and H12 [Срок оценки: 12 hours after the randomization]
- the urine output between H12 and H24 [Срок оценки: 24 hours after the randomization]
- the urine output between H24 and H48 [Срок оценки: 48 hours after the randomization]
- the urine osmolality between H0 and H6 [Срок оценки: 6 hours after the randomization]
- the urine osmolality between H6 and H12 [Срок оценки: 12 hours after the randomization]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Франция · 12 центров
- Médecine Intensive et Réanimation - Centre Hospitalier Universitaire Amiens-Picardie — Amiens
- Médecine Intensive et Réanimation - Hôpital Avicenne — Bobigny
- Réanimation Polyvalente - Hôpital Jean Verdier — Bondy
- Médecine Intensive et Réanimation - Hôpital Louis Mourier — Colombes
- Réanimation Polyvalente et Surveillance continue - Centre Hospitalier Sud Francilien — Corbeil-Essonnes
- Médecine Intensive et Réanimation - Hôpital Henri Mondor — Créteil
- Médecine Intensive et Réanimation - Hôpital François Mitterand — Dijon
- Réanimation Polyvalente - Centre Hospitalier Départemental Vendée — La Roche-sur-Yon
- … и ещё 4 центра
Идентификаторы
NCT: NCT06020495 · APHP220676