Cirrhotic Patients With Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03987048
• Other study ID #: CSSM
• Status: Completed
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18 or older

• diagnosis of cirrhosis

• diagnosis of septic shock at ICU admission

Exclusion Criteria:

• prior liver transplantation

Related Conditions & MeSH terms

• Cirrhosis
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
France	Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term outcome: analysis of independent predictors of ICU mortality rate.	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
Primary	Long-term outcome: analysis of independent predictors of one-year mortality rate.	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)