Cirrhotic Patients With Septic Shock

NCT03987048 | Completed

• 1 other identifier: CSSM
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Cirrhosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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)

Study Arms (1)

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.

Interventions

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.

Cirrhotic patients with septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis who require ICU admission for septic shock

You may qualify if:

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

You may not qualify if:

• prior liver transplantation

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, 69003, France

Location

MeSH Terms

Conditions

Shock, Septic; Fibrosis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: June 14, 2019
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 14, 2019

Record last verified: 2019-05

Locations

FR (1)