Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Diagnostic Test: lung ultrasound-guided fluid resuscitation

• Registration Number: NCT06144463
• Lead Sponsor: Guangdong Second Provincial General Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-13
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Last Update Submitted: 2023-11-26
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Born less than 28 days on admission ;
2. 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 ' ;
3. For children diagnosed with septic shock, fluid resuscitation should be performed according to the routine diagnosis and treatment.
4. The legal guardian has signed the informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LUGFR group	lung ultrasound-guided fluid resuscitation	lung ultrasound-guided fluid resuscitation
traditional group	lung ultrasound-guided fluid resuscitation	Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation.

Primary Outcome Measures

Name	Time	Method
hospitalization time	Within 2 weeks	Primary indicator
mortality	Within 2 weeks	Primary indicator

Secondary Outcome Measures

Name	Time	Method
Use of vasoactive drugs	Within 2 weeks	Secondary Outcome
Cumulative fluid volume	Within 2 weeks	Secondary Outcome
Use of mechanical auxiliary gas	Within 2 weeks	Secondary Outcome

Trial Locations

Locations (1)

Guangdong Second Provincial General Hospital; 🇨🇳 Guangzhou, Guangdong, China