Bacterial sepsis
Conditions
Interventions
control group:Normal saline combined with conventional treatment
Experimental group:Compound amino acids combined with conventional treatment.
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Age: 1 to 18 years old, regardless of gender; 2. Diagnosed with "bacterial sepsis" at the above research institutions between June 2025 and December 2028, with the diagnostic criteria referring to the 2024 international consensus criteria for pediatric sepsis and septic shock: suspected bacterial infection + Phoenix Sepsis Score (PSS) >= 2 points; 3.All patients were enrolled after providing written informed consent, agreeing to the proposed hospitalization, and committing to adhere to the prescribed follow-up protocol.
Exclusion criteria
Exclusion criteria: 1.Those allergic to compound amino acid injection; 2.Comorbidities: viral/fungal infection, chronic renal failure, chronic hepatic failure, severe brain injury, severe malnutrition, metabolic diseases; 3.Disease severity: Cardiopulmonary arrest occurred within the past two hours, requiring cardiopulmonary resuscitation for more than 2 minutes, or death was considered imminent or inevitable during hospitalization; massive hemorrhage with hemorrhagic shock; 4.Those who disagree to participate in the clinical trial or cannot follow up regularly as planned; those who die due to voluntary discharge or withdrawal of treatment for personal reasons; 5.Have participated in another interventional clinical trial within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of death or persistent organ dysfunction within 14 days of hospitalization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of days with persistent fever in children patients;Number of days on invasive mechanical ventilation;Length of stay in PICU;White blood cell count (WBC), procalcitonin (PCT), C-reactive protein (CRP), inflammatory factors (such as IL-6, IL-10, TNF-a), and lactic acid level in the blood;Changes in Pediatric Sequential Organ Failure Assessment (pSOFA score);Number of days of vasoactive drug use; | — |
Countries
China
Contacts
Public ContactChenZhuanggui
The Third Affiliated Hospital Sun Yat-sen University
Outcome results
None listed