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Liver Status in Psychiatric Inpatients (LIVERSPIN)

Primary Purpose

Psychiatric Illness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psychiatric Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre Hospitalier Le VinatierRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All inpatients in Vinatier psychiatric Hospital

Arm Description

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.

Outcomes

Primary Outcome Measures

HCV diagnosis
HCV diagnosis defined by positive HCV antibodies in blood

Secondary Outcome Measures

HBV diagnosis
HBV diagnosis defined by positive HBsAg in blood
HIV diagnosis
HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood
Suspicion of NAFLD
Suspicion of NAFLD on FIB-4 and the interrogation
Suspicion of alcoholic liver disease
Suspicion of alcoholic liver disease on FIB-4 and the interrogation

Full Information

First Posted
January 26, 2022
Last Updated
August 11, 2022
Sponsor
Hôpital le Vinatier
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05213442
Brief Title
Liver Status in Psychiatric Inpatients
Acronym
LIVERSPIN
Official Title
Liver Status in Psychiatric Inpatients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
Collaborators
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Illness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Monocentric, non randomized, non comparative cross-sectional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All inpatients in Vinatier psychiatric Hospital
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.
Intervention Description
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).
Primary Outcome Measure Information:
Title
HCV diagnosis
Description
HCV diagnosis defined by positive HCV antibodies in blood
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
HBV diagnosis
Description
HBV diagnosis defined by positive HBsAg in blood
Time Frame
At inclusion
Title
HIV diagnosis
Description
HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood
Time Frame
At inclusion
Title
Suspicion of NAFLD
Description
Suspicion of NAFLD on FIB-4 and the interrogation
Time Frame
At inclusion
Title
Suspicion of alcoholic liver disease
Description
Suspicion of alcoholic liver disease on FIB-4 and the interrogation
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin ROLLAND, MD, PhD
Phone
+33 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique VIAL
Phone
0033437915522
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin ROLLAND, MD, PhD
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Auvergne Rhone Alpes
ZIP/Postal Code
69678 cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROLLAND BENJAMIN, MD,Ph
Phone
0033 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033 437 915 531
Email
veronique.vial@ch-le-vinatier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Liver Status in Psychiatric Inpatients

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