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临床试验/NCT06144463
NCT06144463已完成不适用

Study on the Application Value of Fluid Resuscitation Guided by Lung Ultrasound in Neonatal Septic Shock

Guangdong Second Provincial General Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
hospitalization time

研究概览

简要总结

object name: Lung ultrasound-guided fluid resuscitation in neonatal septic shock.

type of study: prospective observational study. goal of study: The effects of severe ultrasound-assisted fluid resuscitation and conventional fluid resuscitation on the prognosis of children with neonatal septic shock were compared to evaluate the application value of the two techniques in fluid resuscitation of neonatal septic shock.

research design: In this study, children with neonatal septic shock diagnosed in the neonatal intensive care unit of the Second People 's Hospital of Guangdong Province from January 1,2022 to December 31,2023 were included in the population. According to the different monitoring methods used in conventional / clinical shock treatment, 30 cases of fluid resuscitation assisted by severe ultrasound, 30 cases of fluid resuscitation assisted by NICOM and 30 cases of conventional fluid resuscitation were collected, a total of 90 cases.

( 1 ) The demographic data, blood examination and microbiological examination data of the two groups at admission were collected.

( 2 ) The fluid volume, blood lactic acid, blood pressure, vasoactive drugs ( such as dopamine and epinephrine / norepinephrine ), mechanical ventilation, renal replacement therapy and antibiotic use were collected before fluid resuscitation.

( 3 ) The cumulative fluid infusion volume during fluid resuscitation ( 6 hours ), and the use of vasoactive drugs and mechanical ventilation for 6 hours were collected.

( 4 ) NICU hospitalization time, cumulative hospitalization time and mortality were collected.

Data collection :

( 1 ) The demographic data, blood examination and microbiological examination data of the three groups at admission were collected.

( 2 ) The fluid volume, blood lactic acid, blood pressure, vasoactive drugs ( such as dopamine and adrenaline / norepinephrine ), mechanical ventilation, renal replacement therapy and antibiotic use before fluid resuscitation were collected.

( 3 ) The cumulative fluid infusion volume during fluid resuscitation ( 6 hours ), and the use of vasoactive drugs and mechanical ventilation for 6 hours were collected.

( 4 ) NICU hospitalization time, cumulative hospitalization time and mortality were collected.

详细描述

Efficacy evaluation: The main efficacy criteria: NICU hospitalization time and cumulative hospitalization time, mortality. Secondary efficacy criteria: cumulative fluid volume during fluid resuscitation (6 hours), and use of vasoactive drugs and mechanical ventilation for 6 hours.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Born less than 28 days on admission ;
  • In line with the diagnostic criteria for neonatal septic shock in the ' 2020 International Guidelines for Saving Sepsis Campaign : Management of Sepsis-related Organ Dysfunction in Children ' ;
  • For children diagnosed with septic shock, fluid resuscitation should be performed according to the routine diagnosis and treatment.
  • The legal guardian has signed the informed consent.

排除标准

  • combined with neurogenic shock, trauma and hemorrhagic shock ;
  • symptomatic patent ductus arteriosus ;
  • combined with congenital heart disease ;
  • give up treatment or death within 24 hours of admission ;
  • The legal guardian refused to participate in the study ;
  • Key information and information missing.

结局指标

主要结局

hospitalization time

时间窗: Within 2 weeks

Primary indicator

mortality

时间窗: Within 2 weeks

Primary indicator

次要结局

  • Use of vasoactive drugs(Within 2 weeks)
  • Cumulative fluid volume(Within 2 weeks)
  • Use of mechanical auxiliary gas(Within 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dabin Huang

Doctor

Guangdong Second Provincial General Hospital

研究点 (1)

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