Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care

Liver Cirrhosis Clinical Trial

— STANDAREA  

Official title:

Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494064
• Other study ID #: RCPHRI1018/2
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: December 21, 2015
• Start date: February 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

This study seeks to assess the impact of the standardization of nursing supervision of patients with hepatic encephalopathy using a grid of appropriate surveillance for the prevention of complications in the ICU.

Description:

As part of improving the quality of care, the paramedic team has developed an evaluation grid quantitative parameters of the early warning score, the Glasgow Coma Score modified and signs suggestive of hepatic encephalopathy.A course of action was later formalized as a function of score when using the grid monitoring.

The aim of the study is to demonstrate that the standardization of monitoring by a quantitative evaluation grid reduces the complications of hepatic encephalopathy. For this, investigator's team will study a before / after standardization by comparing two groups of patients, ICU liver - digestive BEAUJON hospital, and suffering from hepatic encephalopathy associated with liver cirrhosis and therapeutic care project formalized. For the first group have been no specific nursing practice, investigator's team will take a retrospective study. For the second group have been monitoring a standard, investigator's team will take a prospective study.

The total number of patients in each group will be 121 a total of 242. The frequency of pneumonia is the primary outcome. Secondary endpoints were the occurrence of ventilatory disorders, the presence of shock and premature death of the patient during his hospitalization. investigator's team will compare the frequency of occurrence of these complications in both groups.

Data will be collected using a questionnaire based on information from the software and GILDAE DXCARE.

The prospective study will last 26 months. For the retrospective study, the MSI will publish a list of all patients meeting the inclusion criteria and ICU liver - digestive in the 26 months preceding the start of the study.

The interest of this work is to formalize an objective tool for assessing hepatic encephalopathy and improve communication among caregivers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA :

• Hepatic encephalopathy

• Liver cirrhosis

• Treatment plan

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Liver Cirrhosis

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of inhalation pneumonia		26 months	No
Secondary	occurrence of ventilatory disorders		26 months	No
Secondary	presence of shock and premature death of the patient.		26 months	No