Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure

Completed

• Conditions: Cirrhosis; Chronic Liver Failure; Acute Liver Failure

• Registration Number: NCT01872767
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

After successful screening diagnosis of cirrhosis and/or acute or chronic liver failure will be made. These patients will undergo detail clinical, biochemical and microbiological examination at baseline. Clinical examination and Biochemical evaluation will be done daily and signs of infection will be noted. Patients will undergo microbiological screening for infection every 48 hours. Patients suspected or diagnosed to be suffering from infections will be treated as per ILBS (Institute of Liver and Biliary Sciences) antibiotic policy. Site and etiology (bacterial and/or fungal) of infections will be noted in all patients at admission in liver specialty ICU (Intensive Care Unit) and during the ICU (Intensive Care Unit) stay. All the patients will be followed until discharge or death in ICU (Intensive Care Unit).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-27
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2015-05-23
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

Inclusion Criteria

• A clinical, radiological or histological diagnosis of cirrhosis and/or ACLF (Acute on Chronic Liver Failure).
• Age > 18years

Exclusion Criteria

• Previous liver transplantation.
• Patients who died within 8 hours of ICU (Intensive Care Unit) admission.
• Acute liver failure
• Lack of consent
• Patient on steroids/ or any other immunosuppressive medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality within 1 month during ICU (Intensive Care Unit) stay.	30 days

Secondary Outcome Measures

Name	Time	Method
Number of days stayed in ICU (Intensive Care Unit).	30 days
Proportion of patients with organ failure.	30 days
Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc	30 days

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences.; 🇮🇳 New Delhi, Delhi, India