Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care (STANDAREA)
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|ClinicalTrials.gov Identifier: NCT01494064|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : December 22, 2015
|Condition or disease|
|Hepatic Encephalopathy Liver Cirrhosis|
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.
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2015|
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
- rate of inhalation pneumonia [ Time Frame: 26 months ]
- occurrence of ventilatory disorders [ Time Frame: 26 months ]
- presence of shock and premature death of the patient. [ Time Frame: 26 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01494064
|Clichy, France, 92110|
|Study Director:||Isabelle Villard||Assistance Publique - Hôpitaux de Paris|