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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Hepatic Encephalopathy

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.

• Study Type: Observational
• Enrollment (Actual): 224

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Hopital Beaujon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

INCLUSION CRITERIA :

• Hepatic encephalopathy
• Liver cirrhosis
• Treatment plan

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective; Included patients have been no specific nursing practice.
Prospective; Standardization of nursing supervision of included patients using a grid of appropriate surveillance for the prevention of complications in the ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of inhalation pneumonia	26 months

Secondary Outcome Measures

Outcome Measure	Time Frame
occurrence of ventilatory disorders	26 months
presence of shock and premature death of the patient.	26 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Isabelle Villard, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: December 14, 2011
• First Posted (Estimate): December 16, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Fibrosis; Brain Diseases, Metabolic; Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: RCPHRI1018/2