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Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care (STANDAREA)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: December 9, 2011
Last updated: December 21, 2015
Last verified: December 2015
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.

Hepatic Encephalopathy
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • rate of inhalation pneumonia [ Time Frame: 26 months ]

Secondary Outcome Measures:
  • occurrence of ventilatory disorders [ Time Frame: 26 months ]
  • presence of shock and premature death of the patient. [ Time Frame: 26 months ]

Enrollment: 224
Study Start Date: February 2011
Study Completion Date: December 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Included patients have been no specific nursing practice.
Standardization of nursing supervision of included patients using a grid of appropriate surveillance for the prevention of complications in the ICU

Detailed 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
ICU patients in Beaujon Hospital as diagnasotic with hepatic encephalopathy and liver cirrhosis and lice which a treatment plan is formalized


  • Hepatic encephalopathy
  • Liver cirrhosis
  • Treatment plan
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Please refer to this study by its identifier: NCT01494064

Hôpital Beaujon
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Study Director: Isabelle Villard Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01494064     History of Changes
Other Study ID Numbers: RCPHRI1018/2
Study First Received: December 9, 2011
Last Updated: December 21, 2015

Additional relevant MeSH terms:
Brain Diseases
Liver Cirrhosis
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases processed this record on May 25, 2017