THERAPEUTIC EFFECT OF KETAMINE NEBULIZATION IN ACUTE RESPIRATORY DISTRESS SYNDROME: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To study the therapeutic effect of ketamine nebulization in ARDS based on Murray Score.
研究概览
简要总结
The aim of study is to estimate the effect of ketamine nebulization in Acute Respiratory Distress Syndrome (ARDS). In this study, 20-50 years old, mechanically ventilated adult patients admitted to the ICU with diagnosis of ARDS (based on Berlin’s criteria) would be included.
The patients will be divided into two groups-
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Group K will be treated with 0.75 mg/kg ketamine (diluted in normal saline to make volume of 5 ml) nebulization 3 times a day in addition to standard treatment of ARDS
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Group C will receive Conventional therapy with nebulization with 5 ml normal saline 3 times a day in addition to standard treatment of ARDS.
The following parameters will be recorded : - Demographic data; APACHE Score at the time of admission; Daily SOFA sco; Daily P/F ratio; Murray Score; IL-6 level on Day 1,3 and 5; 28 days mortality; Sedative requirement; Vasopressor requirement(if any).
Patient will receive therapy uptill - Maximum for 5 days,Or PaO2/FiO2 ≥300, Or patient expires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 20-50 years Mechanically ventilated adult patients admitted to the ICU with developing ARDS.
排除标准
- •Pregnant women Patient/Attendant not giving consent Underlying cardiac, and neurological disorders Previous history of psychiatric disorder / substance abuse APACHE Score ≥25 Patient expiring within 3 days of initiation of therapy.
结局指标
主要结局
To study the therapeutic effect of ketamine nebulization in ARDS based on Murray Score.
时间窗: 28 Days
次要结局
- To evaluate effect of ketamine nebulization on 28 days mortality in ARDS patients(28 days)
- To evaluate the effect of ketamine nebulization on IL-6 levels in ARDS patients on Day 1, 3 & 5.(5 days)
研究者
AMNA KHATOON
KING GEORGE MEDICAL UNIVERSITY, LUCKNOW