Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock

NCT06144463 | Completed DMC

• 1 other identifier: DHuang
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

Lung ultrasound; fluid resuscitation; neonatal septic shock

Outcome Measures

Primary Outcomes (2)

• hospitalization time

  Primary indicator

  Within 2 weeks

• mortality

  Primary indicator

  Within 2 weeks

Secondary Outcomes (3)

• Cumulative fluid volume

  Within 2 weeks

• Use of vasoactive drugs

  Within 2 weeks

• Use of mechanical auxiliary gas

  Within 2 weeks

Study Arms (3)

Control group

NO INTERVENTION

No intervention will be given

traditional group

SHAM COMPARATOR

Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation.

Diagnostic Test: lung ultrasound-guided fluid resuscitation

LUGFR group

EXPERIMENTAL

lung ultrasound-guided fluid resuscitation

Diagnostic Test: lung ultrasound-guided fluid resuscitation

Interventions

lung ultrasound-guided fluid resuscitation DIAGNOSTIC_TEST

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

LUGFR group; traditional group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead

Study Sites (1)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

Location

Related Publications (2)

• 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.

  PMID: 32093763 BACKGROUND

• Huang D, You C, Mai X, Li L, Meng Q, Liang Z. Lung ultrasound-guided fluid resuscitation in neonatal septic shock: A randomized controlled trial. Eur J Pediatr. 2024 Mar;183(3):1255-1263. doi: 10.1007/s00431-023-05371-9. Epub 2023 Dec 14.

  PMID: 38095714 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Zhenyu Liang, Master

  Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)