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临床试验/NCT02460510
NCT02460510已完成不适用

Role of Hypertonic Saline Versus Mannitol in the Management of Raised Intracranial Pressure in Patients With ALF: A Randomized Open -Label Study

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)

研究概览

简要总结

Patients with ALF (Acute liver Failure) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations. Patients would also be screened for the assessment of raised intracranial hypertension by either clinical or neuroimaging or by ONSD (optic nerve sheath diameter) and TCD (Transcranial doppler ultrasonography). Patient found to be having risen ICP (Intra Cranial Pressure) would be randomized in the two groups of the study. The group A would receive intravenous mannitol 20 to 30 minutes every 4 hourly where as those in the group B would be given 3% hypertonic saline as continuous infusion at a rate of 25ml /hr and titrated q4 hrs per sliding scale to achieve a target serum sodium level of 144-155 mmol/L .Both the groups would receive other supportive measures such as head end elevation, oxygen supplementation, dextrose infusion to maintain normoglycemia standard medical treatment.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Acute Liver Failure with age >18 yrs
  • Grade III or grade IV HE with raised ICP
  • Patient's next-of-kin consenting for the study protocol.

排除标准

  • Patients with ocular trauma.
  • K/c/o DCM, congestive heart failure, cerebral aneurysm, intracranial pathology
  • Serum Na>160 and s creat>1.5 mg% with oligurea

研究组 & 干预措施

Mannitol

Experimental

Treatment with mannitol intravenous (IV) bolus over 20 to 30 minutes. The dose is 0.25 g/kg IV as a 20% solution repeated every 4th hourly.(8) Mannitol infusion to be stopped if s osmolarity >320mm

干预措施: Mannitol (Drug)

3% hypertonic saline

Active Comparator

Treatment with 3% hypertonic saline as continuous infusion. Continuous 3% NaCl infusion to be started at a rate of 25ml /hr and titrated q4hrs per sliding scale to achieve a target serum sodium level of <160 mmol/L.

干预措施: 3% hypertonic saline (Drug)

结局指标

主要结局

To study response to therapy at 12 hr in HTS Vs mannitol group in reduction of ICP (Intra Cranial Pressure)

时间窗: 12 hours

ICP (Intra Cranial Pressure) as assessed by ONSD (Optic Nerve Sheet Diameter) \< 5mm PS\<1.2 Pupils - RTL(reaction to light) {if initially NTR(no reaction to light)} BP\<150/90(if initially high) Pulse \>60( if \< 60)

次要结局

  • Survival.(28 days)
  • Correlation of arterial NH3 to raised ICT (Intra cranial Tension).(2 years)
  • Length of ICU/hospital stay.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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