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Changes in the immune system and body composition associated with frailty in liver transplant candidates

Changes in the immune system and body composition associated with frailty in liver transplant candidates - FraiLtx

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033886
Enrollment
81
Registered
2024-03-13
Start date
2024-05-30
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty+ liver failure

Interventions

Group 1: The study examines frailty syndrome in patients presenting to the surgical outpatient unit for evaluation of liver transplantation (liver transplant candidates). These patients will be divide

Sponsors

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Patients with liver disease who present to the general surgical outpatient unit for evaluation of a liver transplant (liver transplant candidates) -Written declaration of consent from the patient

Exclusion criteria

Exclusion criteria: - Legal care, e.g. due to severe dementia or severe psychiatric disorders/illness (biopolar disorder, schizophrenia) - Acute infection - Participation in a clinical trial (intervention study) within the last 30 days - Current participation in another clinical trial (intervention study) - Participation of the patient in this study at an earlier point in time

Design outcomes

Primary

MeasureTime frame
The aim of this study is to investigate the possible association of frailty with an expansion of intermediate monocytes and increased inflammatory parameters in liver transplant candidates. Furthermore, the body composition of these patients will be analyzed in order to establish a body composition phenotype of patients with frailty. Frailty is measured using an index that was developed specifically for patients with liver disease (Liver Frailty Index). To determine this index, three functional tests (handgrip strength, timed chair stands and balance test) are carried out. If the Liver Frailty Index is =4.5, the patient is considered frail. The monocytes in the blood are examined using FACS and the inflammation parameters are measured using multiplex analysis. The body composition is analyzed using echo MRI. The Liver Frailty Index is taken as standard in the general surgery outpatient clinic on presentation for liver transplantation. The blood sample and the echo MRI are taken within a week.

Secondary

MeasureTime frame
The secondary aim of this study is to investigate whether frailty or inflammation (especially expansion of intermediate monocytes) is associated with increased mortality in patients after liver transplantation.

Countries

Germany

Contacts

Public ContactAnna Lulu Homayr

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin

annalulu.homayr@uksh.de+4943150066744

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026