Liver Status in Psychiatric Inpatients

Psychiatric Illness Clinical Trial

— LIVERSPIN  

Official title:

Liver Status in Psychiatric Inpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213442
• Other study ID #: 2021-A02796-35
• Status: Completed
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Psychiatric Illness

Intervention

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).

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Auvergne Rhone Alpes

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital le Vinatier	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV diagnosis	HCV diagnosis defined by positive HCV antibodies in blood	At inclusion
Secondary	HBV diagnosis	HBV diagnosis defined by positive HBsAg in blood	At inclusion
Secondary	HIV diagnosis	HIV diagnosis defined by positive anti-HIV1 or anti-HIV2 antibodies in blood	At inclusion
Secondary	Suspicion of NAFLD	Suspicion of NAFLD on FIB-4 and the interrogation	At inclusion
Secondary	Suspicion of alcoholic liver disease	Suspicion of alcoholic liver disease on FIB-4 and the interrogation	At inclusion