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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01872767
First received: April 27, 2013
Last updated: April 9, 2015
Last verified: November 2014
  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,Recent Hospitalization, recent antibiotic usage, SBP (spontaneous bacterial peritonitis)prophylaxis, diabetes etc [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Proportion of patients with organ failure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 522
Study Start Date: June 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cirrhotics/ Acute on chronic liver failure admitted to ICU

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
India
Institute of Liver & Biliary Sciences.
New Delhi, Delhi, India, 110070
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: April 9, 2015
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:
End Stage Liver Disease
Liver Cirrhosis
Liver Failure
Liver Failure, Acute
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases

ClinicalTrials.gov processed this record on May 25, 2015