Health Condition 1: null- children with fluid refractory septic shock
Conditions
Interventions
Intervention1: Epinephrine: Intravenous infusion of epinephrine, starting dose of 0.1 micg/Kg/min to max of 0.3 mice/kg/min, duration: minimum 48 hours after hemodynamic stabilisation
Control Interven
Sponsors
Post graduate institute of medical education and research chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: All children with fluid refractory septic shock defined as [Persistence of signs of shock despite administration of isotonic intravenous fluid bolus 40 mL/kg or adequate fluid resuscitation until signs of fluid overload (i.e., the development of increased work of breathing, rales, gallop rhythm, or hepatomegaly) develops, there is systolic blood pressure = 70 mm Hg in infant; >= 70 + (2 X age) after 1 year of age)], will be enrolled in the study
Exclusion criteria
Exclusion criteria: (i) Children with known case of congenital heart disease, dilated cardiomyopathy and rhythm disturbance (ii) Children on vasoactive agents started from outside hospitals at presentation to paediatric emergency (iii) Children who have received immunosuppressive or steroid therapy within 6 weeks of presentation with septic shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of septic shock. (Shock reversal will be defined when the following end points are reached. Systolic BP more than 5th percentile for age, with â?¢ Heart rate within normal for age â?¢ Urine output 1 mL/kg/hr â?¢ Capillary refill time less than 3 sec â?¢ Normal mental status (except in cases of suspected meningitis and on sedation) Timepoint: within one hour of inclusion in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| (vi) Incidence of adverse events (Ventricular arrhythmias, atrial fibrillation, peripheral gangrene, skin necrosis or intracranial bleed)Timepoint: Till trial vasoactive agents are discontinued;Day-28 all-cause mortalityTimepoint: From the time of inclusion into the study;Length go mechanical ventilationTimepoint: From the time of initiation of mechanical ventilation to discontinuation of mechanical ventilation;Length of PICU stayTimepoint: From the point of inclusion in the study;Neurological and functional outcomeTimepoint: one, three and five years from the time of inclusion into the study;Requirement of other vasoactive agents (assessed by comparing daily inotropic score between the two groups)Timepoint: From inclusion into the study;Time to normalisation of SscvO2 and lactateTimepoint: From the time of inclusion into the study | — |
Countries
India
Contacts
Public ContactKarthik Narayanan
Post graduate institute of medical education and research
Outcome results
None listed