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: Completed
• Conditions: Psychiatric Illness
• Intervention / Treatment: Diagnostic test: To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.

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: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Auvergne Rhone Alpes
    • Bron, Auvergne Rhone Alpes, France, 69678 cedex
      • Centre Hospitalier le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

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.

Diagnostic test: To estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.; 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	HCV diagnosis defined by positive HCV antibodies in blood	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV diagnosis	HBV diagnosis defined by positive HBsAg in blood	At inclusion
HIV diagnosis	HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood	At inclusion
Suspicion of NAFLD	Suspicion of NAFLD on FIB-4 and the interrogation	At inclusion
Suspicion of alcoholic liver disease	Suspicion of alcoholic liver disease on FIB-4 and the interrogation	At inclusion

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: Benjamin ROLLAND, MD, PhD, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2021-A02796-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No