Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care
NCT ID: NCT01494064
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
224 participants
OBSERVATIONAL
2011-02-28
2015-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
Study Groups
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Retrospective
Included patients have been no specific nursing practice.
No interventions assigned to this group
Prospective
Standardization of nursing supervision of included patients using a grid of appropriate surveillance for the prevention of complications in the ICU
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Liver cirrhosis
* Treatment plan
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Isabelle Villard
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Beaujon
Clichy, , France
Countries
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Other Identifiers
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RCPHRI1018/2
Identifier Type: -
Identifier Source: org_study_id