Clinical trial NCT01494064: Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care
Official title: Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Encephalopathy
Liver Cirrhosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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

Brief 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.

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.

Eligibility criteria: INCLUSION CRITERIA :

* Hepatic encephalopathy
* Liver cirrhosis
* Treatment plan

Primary outcomes:
measure: rate of inhalation pneumonia
timeFrame: 26 months
Secondary outcomes:
measure: occurrence of ventilatory disorders
timeFrame: 26 months
measure: presence of shock and premature death of the patient.
timeFrame: 26 months
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Villard
role: STUDY_DIRECTOR
References: