Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Combination therapy of Norepinephrine and Milrinone infusion: Combination therapy of Norepinephrine and Milrinone will be used as a first line inotropic agent in fluid refractory Pediat
Sponsors
AIIMS RISHIKESH
Eligibility
Inclusion criteria
Inclusion criteria: Children aged one month to 18 years with septic shock, defined as children with suspect or confirmed sepsis and cardiovascular dysfunction, who are fluid refractory, defined as the persistence of features of poor perfusion even after 40 ml/kg of fluid boluses or having clinical features of fluid overload
Exclusion criteria
Exclusion criteria: 1. Children with Fulminant myocarditis 2. Children with Congenital heart disease, cardiomyopathy 3. Children already on inotropes at the time of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of children attaining shock resolution (achieving all therapeutic endpoints of shock) at 6 hoursTimepoint: Six hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of children achieving therapeutic endpoints at 1st and 24 hours of resuscitation 2. All-cause mortality at discharge or day 28 (whichever is earlier) and duration of PICU stay 3 . Occurrence of adverse events, i.e., tachycardia, tachyarrhythmia (Paroxysmal ventricular tachycardia, ventricular tachycardia, ventricular fibrillation), lactic acidosis, acute kidney injury, digital ischemia (gangrene, peripheral mottling) 4. Maximum Vasoactive inotrope score on days 1, 2, and 3 and duration of inotropes 5. PSOFA score and PELOD-2 score at 24, 48 and 72 hours.Timepoint: 1.First and 24 hours 2.At discharge or at day 28 (whichever is earlier) 3. Occurrence of adverse events in 1st 72 hours 4. 72 hours 5.At 24, 48 and 72 hours | — |
Countries
India
Contacts
Public ContactDr Lokesh Tiwari
AIIMS Rishikesh
Outcome results
None listed