Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: High dose probiotics: A high dose multi-strain probiotic product produced by sun pharmaceutical of the brand name of VSL-3 would be given to the intervention arm. It would be dissolve
Sponsors
Postgraduate Institute of Medical Education and Research Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age:18-90 years 2.An increase in SOFA score of 2 or more alongwith documented source of infection anywhere, proven either clinically or by laboratory/radiological investigation/s
Exclusion criteria
Exclusion criteria: 1)Age less than 18 years 2)Contraindication to start enteral feed, 3)Immunodeficiency or malignancy, 4)Prior steroids or immunotherapy, 5)Probiotics intake in last one month 6)Those who are not giving written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine any reduction in hospital mortality and 28 day mortality in patients with confirmed diagnosis of sepsis receiving enteral high dose probiotic supplementationTimepoint: At hospital disposition and 28 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Ascertain the effect of enteral probiotic supplementation on: 1. Duration of ICU/hospital stay 2. Duration of mechanical ventilation, in patients requiring mechanical ventilation 3.Requirement of renal replacement therapy 4.Requirement of vasoactive agents and duration of such need 5. Trends of severity of illness [APACHE II] and organ dysfunction scores (SOFA) Timepoint: At patients disposal from hospital and at 28 days from inclusion in study | — |
Countries
India
Contacts
Public ContactRudra Narayan Swain
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed