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Cirrhotic Patients With Septic Shock

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ClinicalTrials.gov Identifier: NCT03987048
Recruitment Status : Completed
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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.

Condition or disease Intervention/treatment
Septic Shock Cirrhosis Other: Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.

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Study Type : Observational
Actual Enrollment : 149 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome
Actual Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

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.





Primary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cirrhosis who require ICU admission for septic shock
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • prior liver transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987048


Locations
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France
Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)
Lyon, France, 69003
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03987048     History of Changes
Other Study ID Numbers: CSSM
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation