Clinical trial NCT06144463: Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock
Official title: Study on the Application Value of Fluid Resuscitation Guided by Lung Ultrasound in Neonatal Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Lung ultrasound
fluid resuscitation
neonatal septic shock
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hospitalization time
timeFrame: Within 2 weeks
measure: mortality
timeFrame: Within 2 weeks
Secondary outcomes:
measure: Cumulative fluid volume
timeFrame: Within 2 weeks
measure: Use of vasoactive drugs
timeFrame: Within 2 weeks
measure: Use of mechanical auxiliary gas
timeFrame: Within 2 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second Provincial General Hospital
state: Guangdong
Study officials:
affiliation: Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China
name: Zhenyu Liang, Master
role: STUDY_DIRECTOR
References:
citation: 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.