Health Condition 1: null- septic shock after initial resuscitation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 3 months to 12 completed year admitted to emergency/PICU that fulfilled the criteria for septic shock as per the definition of International pediatric sepsis consensus conference: 2005.
Exclusion criteria
Exclusion criteria: 1. Inotrope requirement > 0.3mcg/kg/min of combined total of Epinephrine and Nor-Epinephrine infusion. 2. Child with severe malnutrition ( 4. Child with clinically suspected cardiogenic shock/myocarditis/acquired and congenital heart diseases. 5. Children with raised ICP. 6. Cardiopulmonary arrest prior to randomization. 7. Patients with known immunodeficiency condition, malignancies and/or on chemotherapy. 8. Patient with fulminant liver failure 9. Patients with nephrotic syndrome or protein loosing enteropathies. 10. Patients who had received IV fluids from outside for more than 24 hours prior to presentation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of PICU stayTimepoint: Until child weaned off ventilator as well as off inotropes or The end of protocol (10 days) Whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All cause mortality at 60 days. 2. Organ failure free days from day 1 to day 28. 4. Ventilation free days from day 1 to 28days. 5. Number of organ failures in two groups. 6. Inotrope requirement. 7. Incidence and severity of Acute Lung Injury (ALI) and Acute Kidney Injury (AKI). Timepoint: child is weaned off ventilator as well as off inotropes or The end of protocol (10 days) Whichever is earlier | — |
Countries
India
Contacts
PGIMER, CHANDIGARH