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Clinical Trials/NCT06144463
NCT06144463
Completed
N/A

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

Guangdong Second Provincial General Hospital1 site in 1 country72 target enrollmentJanuary 1, 2022
ConditionsSeptic Shock

Overview

Phase
N/A
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Guangdong Second Provincial General Hospital
Enrollment
72
Locations
1
Primary Endpoint
hospitalization time
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dabin Huang

Doctor

Guangdong Second Provincial General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

hospitalization time

Time Frame: Within 2 weeks

Primary indicator

mortality

Time Frame: Within 2 weeks

Primary indicator

Secondary Outcomes

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

Study Sites (1)

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