- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213442
Liver Status in Psychiatric Inpatients (LIVERSPIN)
Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).
The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.
The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology
Study Overview
Status
Conditions
Detailed Description
The LIVERSPIN study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Auvergne Rhone Alpes
-
Bron, Auvergne Rhone Alpes, France, 69678 cedex
- Centre Hospitalier Le Vinatier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >18 years old
- Social insurance
- Current hospitalization in any psychiatric unit of the participating center
- Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
- Information given to the curator(for people under curatorship)
Exclusion Criteria:
- - Clinical state of the patient which do not allow the collection of study data (according to the investigator)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: All inpatients in Vinatier psychiatric Hospital
All hospitalized patients can potentially be recruited.
They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up.
For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.
|
Patients will receive the usual clinical and paraclinical examinations as part of their hospitalization diagnostic workup. For the biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination. Data will be collected from the patient, or if necessary from the health care team, using the medical record (interview and/or self-questionnaires). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HCV diagnosis
Time Frame: At inclusion
|
HCV diagnosis defined by positive HCV antibodies in blood
|
At inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBV diagnosis
Time Frame: At inclusion
|
HBV diagnosis defined by positive HBsAg in blood
|
At inclusion
|
|
HIV diagnosis
Time Frame: At inclusion
|
HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood
|
At inclusion
|
|
Suspicion of NAFLD
Time Frame: At inclusion
|
Suspicion of NAFLD on FIB-4 and the interrogation
|
At inclusion
|
|
Suspicion of alcoholic liver disease
Time Frame: At inclusion
|
Suspicion of alcoholic liver disease on FIB-4 and the interrogation
|
At inclusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin ROLLAND, MD, PhD, CH le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A02796-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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