Cirrhotic Patients With Septic Shock

June 13, 2019 updated by: Hospices Civils de Lyon

Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome

Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cirrhosis who require ICU admission for septic shock

Description

Inclusion Criteria:

  • age 18 or older
  • diagnosis of cirrhosis
  • diagnosis of septic shock at ICU admission

Exclusion Criteria:

  • prior liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cirrhotic patients with septic shock
All consecutive adult cirrhotic patients admitted to the ICU with septic shock from 2002 to 2013.
Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.

Data were collected regarding medical background, medical condition and management, both at admission and during the ICU stay. These included demographics, clinical, biological and therapeutic data.

Outcome at ICU discharge and at one year were also recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term outcome: analysis of independent predictors of ICU mortality rate.
Time Frame: Between ICU admission (from January 2002 to December 2013) and ICU discharge

The predictors assessed independently are the clinical data, site of infection, biological data, liver scoring systems, organ failure, organ support and simplified acute physiology score (SAPS II), expressed in percentage of patients.

The mortality rate is expressed in percentage of patients.
Between ICU admission (from January 2002 to December 2013) and ICU discharge
Long-term outcome: analysis of independent predictors of one-year mortality rate.
Time Frame: At one year after ICU admission (from January 2002 to December 2013)

The predictors assessed independently are the independent predictors found to be related to the short-term mortality rate, expressed in percentage of patients.

The mortality rate is expressed in percentage of patients.
At one year after ICU admission (from January 2002 to December 2013)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 3, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSSM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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