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

Spectrum, Profile and Outcome of Infections in Patients With Cirrhosis and/ or Acute on Chronic Liver Failure Admitted in Liver Specialty ICU (Intensive Care Unit)- An Observational Study

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 522

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Tertiary Care Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cirrhotics/ Acute on chronic liver failure admitted to ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality within 1 month during ICU (Intensive Care Unit) stay.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of days stayed in ICU (Intensive Care Unit).	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
Proportion of patients with organ failure.	30 days

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Amrish Sahney, MD, Institute of Liver & Biliary Sciences.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 27, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 23, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Acute on Chronic Liver Failure (ACLF),Cirrhosis,; Institute of Liver & Biliary Sciences (ILBS)
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; End Stage Liver Disease; Fibrosis; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Liver Cirrhosis; Liver Failure, Acute
• Other Study ID Numbers: ILBS-ACLF-0003