Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Goal directed therapy group: GDT group will undergo IJV central line insertion and targeting ScvO2 more than 70% by fluids, vasoactive and blood products. ScvO2 may be continuous or int
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: i. All children >= 6 month to AND ii. Presenting to Pediatric ER with clinical septic shock OR iii. Developing it within 24 hours of admission to Pediatric ER Septic shock will be defined by presence of clinically suspected sepsis with cardiovascular organ dysfunction i.e., children with persistent hypotension (MAP <5th centile for age and gender) despite 40 ml/kg of resuscitation fluid and requiring vasoactive drug infusion during first 1 hour.
Exclusion criteria
Exclusion criteria: i. Contraindications for central neck venous line insertion (IJV or Subclavian vein) like bleeding tendencies, or not accessible for line insertion due to short neck or local disease. ii. Children already on inotrope with inotrope score of >10 at arrival to our hospital. iii. Children with known or suspected congenital heart disease iv. Immunocompromised patients, e.g., primary immunodeficiency disorders, HIV (exposed or positive), patients with malignancies or other diseases on immunosuppressive medications including steroids. v. Children with chronic illness like tuberculosis, chronic liver disease, chronic kidney disease, chronic respiratory disease etc. vi. Known Inborn errors of metabolism vii. Children with shock primarily due to diarrhea and severe dehydration. viii.Children with suspected healthcare associated infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MortalityTimepoint: 14 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Care Areas free days in 14 days in the two groupsTimepoint: 14 days;Duration of vasoactive support in the two groupsTimepoint: 5 days;Inotrope free days in 120 hours in the two groupsTimepoint: 5 days;Length of Acute Care Area stayTimepoint: 28 days;Length of hospital stayTimepoint: 28 days;To assess the baseline and trend of ScvO2 in the two groupsTimepoint: 5 days;To compare Organ dysfunction scores (pediatric SOFA and PeLOD) over first 7 days in the two groupsTimepoint: 7 days;To compare the effect of continuous versus intermittent ScvO2 monitoring on achievement of end points as defined above and mortality.Timepoint: 14 days;To compare the time to attainment of end points of shock resuscitation (as defined by BP less than 5th centile MAP for the age and gender, CFT 2 sec, SpO2 70%, and lactate 2 mmol/L)Timepoint: 5 days;To study the correlation of ScvO2 with lactate in the two groups.Timepoint: 5 days | — |
Countries
India
Contacts
Public ContactNamita Ravikumar
Postgraduate Institute of Medical Education and Reasearch
Outcome results
None listed