Comparison of the Efficacy of Renaline and Dopamine in the Treatment of Fluid Refractory Septic Shock in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
This study compares the efficacy of two drugs i.e Adrenaline and dopamine in fluid refractory type of septic shock which is a dreadful medical condition especially in children. The efficacy will be checked based on heart rate , GCS, capillary refill time , palpable pripheral pulse , urine output and systolic blood pressure.
详细描述
This is a randomized control trial in which children / patients diagnosed with Fluid refractory Septic shock will be provided with one of the two drugs ina randomzied way and their efficacy will be assesed on the basis of correction of various parameters at various points of time.
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
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both Genders having age range between 1month and 12 years with diagnosis of fluid refractory septic shock as per operational definition.
排除标准
- •Patients with
- •cardiopumonary Bypass during last 5 days
- •Chronic Systemic disease like Chronic kidney Disease , cerebral palsy, congenital heart disease
- •neuromuscular discorder
- •Metabolic disorders
- •Those who already had treatment at periphery for hypovolemia without any record of medication or sequential organ failure at presentation
研究组 & 干预措施
Group A
These patients will receive 0.1-0.3ug/kg/min of adrenaline when diagnosed with fluid refractory Septic shock .
干预措施: Adrenaline (Drug)
Group B
The patients in this arm of study will be provided with dopamine 10-20ug/kg/min when diagnosed with fluid refractory septic shock.
干预措施: Dopamine (Drug)
结局指标
主要结局
Blood Pressure
时间窗: 6 hours
The blood pressure of the patients will be meaures after administration of each drug at 20 mins and 6 hours.
Pulse
时间窗: 6 hours
The pulse will be compared after adminitration of both drugs at 20 mins and 6 hours
Capillary Refill Time
时间窗: 6 Hours
Capillary Refill time will be assessed after administration of each drug at 20 mins and 6 hours
Urine output
时间窗: 6 hours
Urine output will be calculated from the time of administration of each drug at 20mins and 6 hours and comapred.
GCS
时间窗: 6 hours
Glascow Comma Scale (GCS) will be asses at 20 mins and 6 hours after administration of each drug
次要结局
- SOFA ( Sequential Organ Failure Assesment)(6 Hours)
研究者
Laiba Qamar
Sponsor Investigator
University of Health Sciences Lahore