NCT01494064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

3.7 years

First QC Date

December 9, 2011

Last Update Submit

December 21, 2015

Conditions

Hepatic EncephalopathyLiver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • rate of inhalation pneumonia

    26 months

Secondary Outcomes (2)

  • occurrence of ventilatory disorders

    26 months

  • presence of shock and premature death of the patient.

    26 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Hepatic encephalopathy
  • Liver cirrhosis
  • Treatment plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Hepatic EncephalopathyLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabelle Villard

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 16, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations

FR(1)