Randomised control study - To study effect of metabolic resuscitation with thiamine & vitamin C, B12 in pediatric severe sepsis

Rainbow childrens hospital1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2020年11月15日最近更新: 2022年2月17日

试验速览

阶段: 不适用
状态: 招募中
发起方: Rainbow childrens hospital
入组人数: 200
试验地点: 1
主要终点: Mortality Benefits

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

All cases of pediatric severe sepsis and septic shock patients are randomised to study group and control group. Study group would receive Inj thiamine,inj Vitamin C, Inj Vitamin B12 for 3 days along with standard treatment as per PICU protocol and control group would receive only standard treatment as per PICU protocol. Multiple variants including mortality benefits, SOFA score,VIS score, lactate levels , duration of hospital stay will be compared among the study and control groups.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

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

入选标准

•All Cases of Severe sepsis and septic shock will be categorised to study grup and control group.
•Study group will receive inj Thiamine, vitamin C, Vitamin B12 along with standard treatment as per PICU protocol.
•Control group would receive only standard treatment as per PICU protocol.

排除标准

•KNOWN CASE OF VITAMIN C,THIAMINE, B12 Deficiency cases of dilated cardiomyopathy INBORN ERROR OF METABOLISM RENAL STONES ALLERGY TO VITAMIN C, THIAMINE, B12.

结局指标

主要结局

Mortality Benefits

时间窗: Mortality Benefits

次要结局

Lactate levels,(SOFA Scores)

研究者

发起方

Rainbow childrens hospital

申办方类型

Private hospital/clinic

研究点 (1)

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