Severe Pneumonia in Children
Conditions
Interventions
Experimental group:After the patients are included in the group, the medication should be started within 2 hours. Dilute the 1-day dose (0.2mg/kg/h) with 48ml of normal saline. Administer it continuou
Control group:None
Sponsors
The First Affiliated Hospital of Henan Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Age between 3 years and 14 years, regardless of gender; 2. Diagnosis meets the clinical criteria for severe pneumonia according to China's "Guidelines for the Management of Community-Acquired Pneumonia in Children (2024 Revision)", with any of the following: (1) Poor general condition (e.g., marked fatigue, unwilling to move / minimal interaction); (2) Refusal to eat or inability to feed; (3) Consciousness disturbance / drowsiness / coma; (4) Significantly increased respiratory rate, infants >=70 times/min, older children >=50 times/min; (5) Cyanosis; (6) Difficulty breathing; (7) Oxygen saturation (SpO2) =2/3 involvement; (9) Presence of pleural effusion; (10) Presence of extrapulmonary complications; 3. Non-intubated patients; 4. Time from diagnosis of severe pneumonia to enrollment <24 hours; 5. Legal guardian fully understands the purpose and significance of this trial and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who have been confirmed to have ARDS; 2. Those who have had an allergic reaction to levosimendan or its excipients in the past; 3. Those with severe liver or kidney dysfunction or other underlying diseases; 4. Congenital heart disease, asthma, upper airway obstruction; 5. Premature birth history (corrected gestational age = 2 is considered as "acute functional impairment of this organ")
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of ARDS within 7 days after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement within 14 days;Time to ARDS onset;Total hospitalization cost;Dynamic changes in oxygenation index;Pulmonary imaging changes;Total length of hospital stay;Neutrophil-to-lymphocyte ratio (NLR);Platelet-to-lymphocyte ratio (PLR);Plasma neutrophil elastase (NE) level;28-day mortality;IL-6;CRP;PCT;Change in pSOFA score;Endotracheal intubation rate;Incidence of multiple organ failure within 7 days;Incidence of adverse events (AEs);Incidence of serious adverse events (SAEs);Incidence of liver function abnormalities;Incidence of ECG abnormalities; | — |
Countries
China
Contacts
Public ContactLi Shujun
The First Affiliated Hospital of Henan Medical University
Outcome results
None listed