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OpenTrials
Completed

NCT Number: NCT03987048

Cirrhotic Patients With Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • prior liver transplantation

Treatment and study plan

Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 14, 2019
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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