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临床试验/CTRI/2024/06/069348
CTRI/2024/06/069348尚未招募不适用

Assessment of the Peripheral venous to arterial pCO2 gap in Paediatric Septic Shock

Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Change in peripheral venous to arterial pCO2 gap

研究概览

简要总结

This study is an prospective observational study to assess the peripheral venous to arterial pCO2 gap in paediatric septic shock and it will be conducted in the department of Paediatrics of Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. The primary objective is to determine the change in the peripheral venous to arterial pCO2 gap at 1 hour and 6 hours from the baseline. The secondary objectives are to determine the proportion of patients having high peripheral venous to arterial pCO2 gap at 0 hour, 1 hour and 6 hours; to compare the peripheral venous to arterial pCO2 gap with the outcome and to compare the peripheral venous to arterial pCO2 gap and lactate clearance. Our hypothesis is that the septic shock patients having high peripheral venous to arterial pCO2 gap will have poorer outcomes because of circulatory failure and those patients showing response to treatment in the form of improving pCO2 gap will have better outcomes as compared to those persistently having high peripheral venous to arterial pCO2 gap.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group 1 month to 12 years presenting with septic shock as per the Phoenix Sepsis Criteria given by the International SCCM Paediatric Sepsis Definition Task Force in January 2024.

排除标准

  • Patients who have received fluid boluses or inotropes before presenting in our Paediatrics department 2) Patients who are a known case of cyanotic heart disease and with a known right to left shunt lesion 3) Patients who are a known case of chronic lung disease and chronic kidney disease 4) Patients who are a known case of vasculitis and gangrene 5) Patients who are a known case of cytotoxic hypoxia.

结局指标

主要结局

Change in peripheral venous to arterial pCO2 gap

时间窗: At 1 hour and 6 hours from 0 hour of treatment

次要结局

  • Proportion of patients having high peripheral venous to arterial pCO2 gap(At 0 hour, 1 hour and 6 hours of treatment)
  • Comparison of the proportion of patients having high peripheral venous to arterial pCO2 gap between survivors and non survivors(At the time of discharge/death)
  • Comparison of the proportion of patients having high peripheral venous to arterial pCO2 gap between patients achieving and not achieving shock reversal(Within 6 hours of treatment)
  • Correlation of peripheral venous to arterial pCO2 gap and lactate clearance(At 1 hour and 6 hours of treatment)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Harshit Mittal

Maulana Azad Medical College

研究点 (1)

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