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

NCT01872767 | Completed

• 1 other identifier: ILBS-ACLF-0003
• Study Type: observational
• Target: 522
• Locations: 1 country
• Sites: 1

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).

Conditions

Cirrhosis; Acute Liver Failure; Chronic Liver Failure

Keywords

Acute on Chronic Liver Failure (ACLF),Cirrhosis,; Institute of Liver & Biliary Sciences (ILBS)

Outcome Measures

Primary Outcomes (1)

• Mortality within 1 month during ICU (Intensive Care Unit) stay.

  30 days

Secondary Outcomes (3)

• 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

Study Arms (1)

Cirrhotics/ Acute on chronic liver failure admitted to ICU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary Care Center.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences.

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Fibrosis; Liver Failure, Acute; End Stage Liver Disease; Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Amrish Sahney, MD

  Institute of Liver & Biliary Sciences.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2013
• First Posted: June 7, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2014-11

Locations

IN (1)