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

This study is currently recruiting participants.
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

December 9, 2011
March 12, 2014
February 2011
October 2014   (final data collection date for primary outcome measure)
rate of inhalation pneumonia [ Time Frame: 26 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01494064 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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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

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.

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.

Observational
Observational Model: Cohort
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Probability Sample

ICU patients in Beaujon Hospital as diagnasotic with hepatic encephalopathy and liver cirrhosis and lice which a treatment plan is formalized

  • Hepatic Encephalopathy
  • Liver Cirrhosis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
121
January 2015
October 2014   (final data collection date for primary outcome measure)

INCLUSION CRITERIA :

  • Hepatic encephalopathy
  • Liver cirrhosis
  • Treatment plan
Both
18 Years and older
No
Contact: Coralie Villeret 01 40 27 52 66 coralie.villeret@sls.aphp.fr
France
 
NCT01494064
RCPHRI1018/2
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Director: Isabelle Villard Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP