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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872767
• Other study ID #: ILBS-ACLF-0003
• Status: Completed
• Phase: N/A
• First received: April 27, 2013
• Last updated: May 23, 2015
• Start date: June 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Liver Failure
• Chronic Liver Failure
• Cirrhosis
• End Stage Liver Disease
• Liver Cirrhosis
• Liver Failure
• Liver Failure, Acute

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences.	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 1 month during ICU (Intensive Care Unit) stay.		30 days	Yes
Secondary	Number of days stayed in ICU (Intensive Care Unit).		30 days	Yes
Secondary	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	No
Secondary	Proportion of patients with organ failure.		30 days	Yes