A prospective observational study to evaluate the prescribing pattern and microbial sensitivity of antimicrobial agents in Gram-negative severe sepsis/septic shock patients in medical intensive care unit at tertiary care hospital.
- Conditions
- Severe Sepsis/ Septic Shock
- Registration Number
- CTRI/2014/03/004441
- Lead Sponsor
- Not Applicable
- Brief Summary
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| Protocol Title
A prospective observational study to evaluate the prescribing pattern and microbial sensitivity of antimicrobial agents in Gram-negative severe sepsis/septic shock patients in medical intensive care unit at tertiary care hospital.
| Protocol No:
PPMS-01
| Version number
1.0, Dated-5/09/13
| Primary objective
Secondary objective
To evaluate the prescribing pattern and microbial sensitivity of antimicrobial agents in Gram- negative severe sepsis/ septic shock patients in MICU at tertiary care hospital.
1. To determine the epidemiology of Gram- negative severe sepsis/septic shock in MICU at tertiary care hospital.
2. To determine the clinical outcomes of Gram- negative severe sepsis/septic shock patients admitted in the MICU.
| Study design
Prospective Observational study
| Study Duration
6 months
| Methodology
In this study, data of the patients, who suffered from Gram-negative severe sepsis/septic shock, will be collected prospectively, from MICU, Max Super Specialty Hospital, Patpargunj, New Delhi, and the prescribing pattern and microbial sensitivity will be studied and evaluated
| Study Population
Both males and females
| Data Collection
All the variables will be noted in the data collection sheet.
| Ethics and Responsibility
The protocol will be submitted to IEC of Max Super Specialty Hospital.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 85
- •Patients with severe sepsis/septic shock admitted to the medical intensive care unit.
- •Patients aged above 18 years and below 65 years •Patients who are receiving antimicrobial agents.
•Patients with less than 8 hours of length of stay in the ICU.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the major antibiotic prescribed in Gram- negative severe sepsis/ septic shock patients admitted in MICU. After recruitment we analyze our outcome. 2. To determine the Gram- negative micro-organism isolated in the positive culture and their sensitivity against the antimicrobial agents. After recruitment we analyze our outcome.
- Secondary Outcome Measures
Name Time Method Not Applicable Not Applicable
Trial Locations
- Locations (1)
Max Super Speciality Hospital
🇮🇳Delhi, DELHI, India
Max Super Speciality Hospital🇮🇳Delhi, DELHI, IndiaDrYP SinghPrincipal investigator08800531155yogendra.singh2@maxhealthcare.com