Randomized Controlled Study of the Effectiveness of IV Fluid Infusion in Patients With Acute Ischemic Stroke (IVIS)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- NIHSS ≤ 4
研究概览
简要总结
To study the result of intravenous fluid in patients with acute ischemic stroke within 72 hours.
详细描述
This study aims to find the effect of early IV fluid administration to patients with acute ischemic stroke on the neurological outcome and to determine the side effects of intravenous fluids. Due to its cost effectiveness and wide accessibility, the possible application or use of IV fluid infusion as first line treatment can aide in the treatment of more acute ischemic stroke patients worldwide. This novel information will aide physicians with more comprehensive understanding of the efficacy of utilizing IV fluid in future treatment plans for patients with acute ischemic stroke.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18-80 years
- •Diagnosis of acute ischemic stroke within 72 hours from stroke onset
- •Enrollment into the study within 24 hours after hospital arrival
- •Urine specific gravity level < 1.030
- •Patient consent
排除标准
- •Patients receiving > 40 ml/hr IV fluid infusion over 3 hours
- •Acute ischemic stroke caused cardiogenic embolism
- •Urine specific gravity ≥ 1.030
- •Large cerebral infarction area
- •Infarction > 1/3 of middle cerebral artery area
- •Infarction > 1/2 of cerebellar hemisphere
- •Previous or current episode of atrial fibrillation
- •Previous or current episode congestive heart failure
- •Previous echocardiogram with ejection fraction < 40%
- •Previous or current episode of dilated cardiomyopathy
- •Abnormal renal function GFR ≤ 60% or serum creatinine ≥ 2
- •Modified Rankin scale before acute ischemic stroke ≥ 2
- •Patients receiving intravenous thrombolysis
- •NPO with need for IV fluid
- •IV fluid infusion needed from any other causes
- •Patients with poor prognosis with life expectancy < 90 days
- •Patients involved in other ongoing clinical studies
研究组 & 干预措施
IV Fluid
0.9% NaCl solution infusion: 100 ml/hr for three days.
干预措施: 0.9% NaCl solution (Drug)
结局指标
主要结局
NIHSS ≤ 4
时间窗: day 7 after treatment or on the day of discharge
Patients with good outcome by NIHSS ≤ 4 at day 7 after treatment or on the day of discharge, which ever comes first.
次要结局
- mRS ≤ 1(at day 90)
- mRS ≤ 4(at day 90)
- change of serum osmolarity(at day 3 after treatment)
研究者
Nijasri C Suwanwela
Division of Neurology, Department of Medicine, Faculty of Medicine
Chulalongkorn University