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CompletedNCT01494064

Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care

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

Status
Completed
Phase
Study type
Observational
Enrollment
224 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2011-02-01
Primary completion
2014-10-01
Completion
2015-12-01
First posted
2011-12-16
Last updated
2015-12-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01494064. Inclusion in this directory is not an endorsement.

Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care (NCT01494064) · Clinical Trials Directory