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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01494064
First received: December 9, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition
Hepatic Encephalopathy
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • rate of inhalation pneumonia [ Time Frame: 26 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • occurrence of ventilatory disorders [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • presence of shock and premature death of the patient. [ Time Frame: 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 121
Study Start Date: February 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

INCLUSION CRITERIA :

  • Hepatic encephalopathy
  • Liver cirrhosis
  • Treatment plan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494064

Contacts
Contact: Coralie Villeret 01 40 27 52 66 coralie.villeret@sls.aphp.fr

Locations
France
Hôpital Beaujon Recruiting
Clichy, France, 92110
Contact: Isabelle Villard    01 40 87 52 39    isabelle.villard@bjn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Isabelle Villard Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01494064     History of Changes
Other Study ID Numbers: RCPHRI1018/2
Study First Received: December 9, 2011
Last Updated: March 12, 2014
Health Authority: France: Institutional Ethical Committee

Additional relevant MeSH terms:
Hepatic Encephalopathy
Liver Cirrhosis
Fibrosis
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 22, 2014