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

This study is not yet open for participant recruitment.
Verified December 2013 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01872767
First received: April 27, 2013
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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).


Condition
Cirrhosis
Acute Liver Failure
Chronic Liver Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Mortality within 1 month during ICU (Intensive Care Unit) stay. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of days stayed in ICU (Intensive Care Unit). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Risk factors determination in development of multidrug resistance bacteria.Risk factors are defined as Nosocomial infection,HCA (Health Care Associated)infection,Recent Hospitalization. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of patients with organ failure in both groups. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
subjects with infection at admission.
subjects without infection at admission.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Tertiary Care Center.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872767

Contacts
Contact: Dr Ambrish Sahney, MD +91-11-01146300000 amrish.sahney@gmail.com
Contact: Dr Ankit Bhardwaj +91-011-46300000 bhardwaj.ankit3@gmail.com

Locations
India
Institute of Liver & Biliary Sciences. Not yet recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Amrish Sahney, MD    +91-011-46300000    amrish.sahney@gmail.com   
Principal Investigator: Dr Amrish Sahney, MD         
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Amrish Sahney, MD Institute of Liver & Biliary Sciences.
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01872767     History of Changes
Other Study ID Numbers: ACLF-ILBS-0003
Study First Received: April 27, 2013
Last Updated: December 14, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Institute of Liver and Biliary Sciences, India:
Acute on Chronic Liver Failure (ACLF),Cirrhosis,
Institute of Liver & Biliary Sciences (ILBS)

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Failure
Liver Failure, Acute
End Stage Liver Disease
Liver Diseases
Digestive System Diseases
Pathologic Processes
Hepatic Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014