Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To demonstrate the effectiveness of urea therapy in correcting persistent hyponatremia despite adequate management during subarachnoid hemorrhage
研究概览
简要总结
Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged at least 18 years old
- •Non-traumatic HSA
- •Hyponatremia defined by a natremia less than 135 mmol / L and a high natriuresis, greater than 250 mmol / L despite well-managed saline intakes
排除标准
- •Severe cardiac decompensation (LVEF <30%)
- •Severe hepatic cirrhosis (PT <30%, ascites), known severe renal failure (GFR <30mL / min / 1.73m²)
- •Blood urea> 25 mmol / L in the basal state
- •Osmotherapy and diuretics in the last 48 hours
- •Ongoing treatment with systemic corticosteroids
- •Persons referred to in Articles L1121-5 to L1121-8 of the CSP corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.
- •Patient not affiliated to a social security scheme
- •Known hypersensitivity to any of the components of ergytonyl
- •Contraindications to ergytonyl: taking curative anticoagulants, previously known and treated diabetic patients
研究组 & 干预措施
EXPERIMENTAL GROUP
the experimental group will be treated during 5 days by urea dose per administration : 1g / kg / 24 hours in 2 or 3 doses morning, noon and evening (dose adjustment of urea according to weight)
干预措施: Urea (Drug)
CONTROL GROUP
the control group will be treated during 5 days by ergytonyl dose per administration : 5mL
干预措施: PLACEBO (Other)
结局指标
主要结局
To demonstrate the effectiveness of urea therapy in correcting persistent hyponatremia despite adequate management during subarachnoid hemorrhage
时间窗: 5 days
Change in blood serum in mmol / L measured before initiation of treatment and on the day of discontinuation of treatment
次要结局
- To compare the sodium intake required to correct the natremia.(8 days)
- To assess the impact of treatment on length of stay(3 months)
- To assess the impact of treatment on neurological outcome at 3 months from inclusion(3 months)
- To study the mechanism of action of urea(48 hours after the end of treatment)
- To assess the adverse effects of treatment(3 months)
- Persistence of correction of natraemia 48H after cessation of treatment(48 hours after the end of treatment)
- To compare the speed of correction of natraemia(5 days)