Septic ShockLUGFRINSSNCT06144463
Lung Ultrasound-guided Fluid Resuscitation in Neonatal Septic Shock
A study testing lung ultrasound-guided fluid resuscitation in people with Septic Shock, run by Guangdong Second Provincial General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Septic Shock
- What is being tested?
- lung ultrasound-guided fluid resuscitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Septic Shock
- Being tested
- lung ultrasound-guided fluid resuscitation
- Keywords
- Lung ultrasound, fluid resuscitation, neonatal septic shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound-guided fluid resuscitationDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention will be given |
| traditional group | Sham comparator | Non-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation. Receives: Diagnostic Test: lung ultrasound-guided fluid resuscitation |
| LUGFR group | Experimental | lung ultrasound-guided fluid resuscitation Receives: Diagnostic Test: lung ultrasound-guided fluid resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospitalization time
Primary indicator
Measured: Within 2 weeks
mortality
Primary indicator
Measured: Within 2 weeks
Secondary outcomes (3)
Cumulative fluid volume
Secondary Outcome
Measured: Within 2 weeks
Use of vasoactive drugs
Secondary Outcome
Measured: Within 2 weeks
Use of mechanical auxiliary gas
Secondary Outcome
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Second Provincial General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dabin Huang, Guangdong Second Provincial General Hospital
- Investigators
- Zhenyu Liang, Master, Study director, Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144463
- Sponsor's protocol ID
- DHuang
- Acronym
- LUGFRINSS
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32093763Huang 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.
PubMed 38095714
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application Value of Fluid Resuscitation Guided by Lung Ultrasound in Neonatal Septic Shock
- ClinicalTrials.gov ID
- NCT06144463
- Acronym / sponsor ID
- LUGFRINSS / DHuang
- Conditions
- Septic Shock
- Keywords
- Lung ultrasound, fluid resuscitation, neonatal septic shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Guangdong Second Provincial General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention will be given |
| traditional group | Sham comparator | Diagnostic Test: lung ultrasound-guided fluid resuscitationNon-invasive cardiac output monitoring ( NICOM ) assisted fluid resuscitation. |
| LUGFR group | Experimental | Diagnostic Test: lung ultrasound-guided fluid resuscitationlung ultrasound-guided fluid resuscitation |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasound-guided fluid resuscitationFor 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 | Diagnostic test | LUGFR group, traditional group |
Primary outcome
hospitalization time
Time frame: Within 2 weeks
Primary indicator
mortality
Time frame: Within 2 weeks
Primary indicator
3 secondary outcomes
Cumulative fluid volume
Time frame: Within 2 weeks
Use of vasoactive drugs
Time frame: Within 2 weeks
Use of mechanical auxiliary gas
Time frame: Within 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 32093763Singh 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.
- Derived from this study: PubMed 38095714Huang 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.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenyu Liang, Master study director
Department of Pediatrics, Guangdong Second Provincial General Hospital, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound-guided fluid resuscitation in people with Septic Shock, run by Guangdong Second Provincial General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospitalization time (time frame: Within 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144463, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.