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Study on the application value of mNGS rapid detection in accurate anti-infection diagnosis and treatment of children with septic shock

Study on the application value of mNGS rapid detection in accurate anti-infection diagnosis and treatment of children with septic shock

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070313
Enrollment
Unknown
Registered
2023-04-10
Start date
2022-09-07
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock in children

Interventions

Gold Standard:Gold standard: the type of infectious pathogen is finally determined in the discharge diagnosis, and the judgment result is obtained after comprehensive analysis based on the detection r
Index test:Samples at the same time and at the same place shall be submitted for inspection by two detection methods to detect pathogens: 1. Traditional methods: microscopic examination of pathogen sm

Sponsors

Beijing Children’s Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.1 Years to 18 Years

Inclusion criteria

Inclusion criteria: During the study period, the children who met the diagnosis of septic shock were included in the PICU inpatients of Beijing Children's Hospital.The diagnostic criteria of children with septic shock are based on the diagnostic criteria in the Consensus of Experts on the Diagnosis and Treatment of Children's Septic Shock (2015): septic shock can be diagnosed as septic shock when the patients with sepsis have tissue perfusion insufficiency and cardiovascular dysfunction. It is manifested as (1) hypotension: blood pressure is lower than the 5th percentile of the age group, or systolic blood pressure is lower than 2 standard deviations of the normal value of the age group. (2) It is necessary to use vasoactive drugs to maintain blood pressure within the normal range [dopamine>5ug/kg. min or any dose of dobutamine, norepinephrine and epinephrine. (3) It has three of the following tissue hypoperfusion manifestations: changes in heart rate and pulse: peripheral arterial pulse is weak, and heart rate and pulse are faster. Skin changes: pale or gray, wet and cold, marbled. For example, warm shock can be manifested as warm limbs and dry skin. The capillary refilling time (CRT) is prolonged (>3s) (excluding the influence of ambient temperature), and the CRT can be normal during warm shock. Change of consciousness: early irritability or depression, and indifferent expression. In the late stage, consciousness is blurred, even coma and convulsion. After fluid resuscitation, the urine volume is still less than 0.5 ml/kg. h, lasting for at least 2 hours. Lactic acidosis (excluding other ischemic hypoxia and metabolic factors), arterial blood lactic acid>2mmol/L.

Exclusion criteria

Exclusion criteria: 1. Age: correction age = 18 years for adults; 2. No informed consent of family members; 3. The child died within 48 hours after admission; 4. Incomplete clinical data.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;positive predictive value;negative predictive value;false negative rate;false positive rate;

Secondary

MeasureTime frame
compliance rate;accuracy;

Countries

China

Contacts

Public ContactLijuan Wang

Beijing Children’s Hospital, Capital Medical University

wanglijuandexin@126.com+86 15810377165

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026