Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

Septic Shock Clinical Trial

— LUGFRINSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06144463
• Other study ID #: DHuang
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: Guangdong Second Provincial General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• lung ultrasound-guided fluid resuscitation
For the LUGFR group, therapy was applied based on the same treatment guidelines, and initial lung ultrasonography was performed after enrollment as baseline assessment of lung. The lung ultrasound was conducted using the Doppler ultrasound diagnostic instrument (Philips CX50) at a probe frequency range of 8 to 12 MHz. Lung ultrasonography was conducted using the 12-region method that included the anterior, lateral, and posterior walls on both sides of the lung, which was focused on the condition of A-lines, B-lines (including confluent B-line and compact B-lines), lung consolidation and pleural effusion

Locations

Country	Name	City	State
China	Guangdong Second Provincial General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Second Provincial General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Singh Y, Tissot C, Fraga MV, Yousef N, Cortes RG, Lopez J, Sanchez-de-Toledo J, Brierley J, Colunga JM, Raffaj D, Da Cruz E, Durand P, Kenderessy P, Lang HJ, Nishisaki A, Kneyber MC, Tissieres P, Conlon TW, De Luca D. International evidence-based guidelines on Point of Care Ultrasound (POCUS) for critically ill neonates and children issued by the POCUS Working Group of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). Crit Care. 2020 Feb 24;24(1):65. doi: 10.1186/s13054-020-2787-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospitalization time	Primary indicator	Within 2 weeks
Primary	mortality	Primary indicator	Within 2 weeks
Secondary	Cumulative fluid volume	Secondary Outcome	Within 2 weeks
Secondary	Use of vasoactive drugs	Secondary Outcome	Within 2 weeks
Secondary	Use of mechanical auxiliary gas	Secondary Outcome	Within 2 weeks