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临床试验/CTRI/2024/10/075328
CTRI/2024/10/075328尚未招募3 期

To study the effectiveness of normal saline vs ringers lactate as resuscitative fluids in pediatric patients with shock .

Dr Fatima Huda1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年10月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
Primary objective : to compare level of acidosis (ph and bicarbonate ) in children with shock receiving ringer lactate or normal saline as resuscitative fluid.

研究概览

简要总结

To study effectiveness of normal saline vs ringers lactate as resuscitative fluids in pediatric patients with shock presenting to tertiary care hospital Aurangabad .

Primary objective : To compare level of acidosis (ph. and bicarbonate ) in children with shock receiving ringer lactate or normal saline as resuscitative fluid.

Secondary objective : To compare  :

  1. Metabolic response : Electrolytes : ( sodium , chloride , potassium ) , lactate , renal function tests

  2. Hemodynamic Response : Heart rate , blood pressure

  3. Inflammatory markers : CRP

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Month(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • children included in the study which are more than 1 month upto 18 years of life presenting with shock requiring fluids resuscitation in casualty , ward or picu .

排除标准

  • patients who have been diagnosed with diabetic ketoacidosis 2) patients who have been diagnosed with chronic kidney diseases 3) for patients with inborn errors of metabolism 4) children undergoing chemotherapy.

结局指标

主要结局

Primary objective : to compare level of acidosis (ph and bicarbonate ) in children with shock receiving ringer lactate or normal saline as resuscitative fluid.

时间窗: assessment will be at 0 hours ( i.e before administration of iv fluid as normal saline or ringers lactate ), 6 hours , 12 hours and 24 hours after administration of iv fluid as bolus .

次要结局

  • Secondary objective : to compare: 1) metabolic response : electrolytes (sodium, chloride ,potassium) lactate, renal function tests(2) hemodynamic response :heart rate , blood pressure)

研究者

发起方
Dr Fatima Huda
申办方类型
Other [{principal investigator}-(self)]
责任方
Principal Investigator
主要研究者

Dr. Fatima Huda

MGM MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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