Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock (LUGFRINSS)

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Diagnostic test: lung ultrasound-guided fluid resuscitation

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510317
      • Guangdong Second Provincial General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention will be given
Sham Comparator: traditional group; Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation.	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
Experimental: LUGFR group; lung ultrasound-guided fluid resuscitation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization time	Primary indicator	Within 2 weeks
mortality	Primary indicator	Within 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative fluid volume	Secondary Outcome	Within 2 weeks
Use of vasoactive drugs	Secondary Outcome	Within 2 weeks
Use of mechanical auxiliary gas	Secondary Outcome	Within 2 weeks

Collaborators and Investigators

• Sponsor: Guangdong Second Provincial General Hospital
• Investigators: Study Director: Zhenyu Liang, Master, Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lung ultrasound; fluid resuscitation; neonatal septic shock
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: DHuang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No