Probiotic in adult sepsis patients
Phase 3
- Conditions
- Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/06/034058
- Lead Sponsor
- Postgraduate Institute of Medical Education and Research Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Ascertain the effect of enteral probiotic supplementation on: <br/ ><br>1. Duration of ICU/hospital stay <br/ ><br>2. Duration of mechanical ventilation, in patients requiring mechanical ventilation <br/ ><br>3.Requirement of renal replacement therapy <br/ ><br>4.Requirement of vasoactive agents and duration of such need <br/ ><br>5. Trends of severity of illness [APACHE II] and organ dysfunction scores (SOFA) <br/ ><br>Timepoint: At patients disposal from hospital and at 28 days from inclusion in study