Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period (PREDITH)
Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases.
The expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (< 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score > 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival.
PREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: LEBOSSE Fanny, Dr
- Telefonnummer: +33 4 26 10 93 39
- E-post: fanny.lebosse@chu-lyon.fr
Studera Kontakt Backup
- Namn: DELIGNETTE Marie Charlotte, Dr
- Telefonnummer: +33 4 26 10 90 70
- E-post: marie-charlotte.delignette@chu-lyon.fr
Studieorter
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Clermont-Ferrand, Frankrike, 63100
- Department of Hepatology and Gastroenterology - CHU de Clermont Ferrand
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Kontakt:
- Abergel Armand, Pr
- Telefonnummer: +33 4 73.75.05.04
- E-post: aabergel@chu-clermontferrand.fr
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Lyon, Frankrike, 69004
- Department of Hepatology and Gastroenterology - Hôpital de la Croix-Rousse
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Kontakt:
- LEBOSSE Fanny, Dr
- Telefonnummer: +33 4 26 10 93 39
- E-post: fanny.lebosse@chu-lyon.fr
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Kontakt:
- DELIGNETTE Marie-Charlotte, Dr
- Telefonnummer: +33 4 26 10 90 70
- E-post: marie-charlotte.delignette@chu-lyon.fr
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Montpellier, Frankrike, 34090
- Department of Hepatology and Gastroenterology - Hôpital Saint Eloi
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Kontakt:
- Bedoya Jose Ursic, Dr
- Telefonnummer: 33 4 67.33.70.62
- E-post: jose.ursicbedoya@chu-montpellier.fr
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Kontakt:
- Monet Clément, Dr
- Telefonnummer: +33 4 67.33.02.62
- E-post: c-monet@chu-montpellier.fr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
Patients awaiting liver transplantation for one of the following indications:
- Compensated cirrhosis complicated by hepatocellular carcinoma
- Chronically decompensated cirrhosis (recurrent gastrointestinal bleeding, refractory ascites, portopulmonary or hepatopulmonary syndrome, hepatic encephalopathy, chronic liver failure)
- Acute decompensated cirrhosis, with or without associated multiple organ failure (ACLF)
- Acute fulminant hepatitis
Final inclusion will be :
- Patients receiving LT AND
- Who provided their consent to participate during the initial enrollment visit AND
- For whom the baseline sample (during the day of the LT) was collected
Exclusion Criteria:
- Minors
- Patients under legal guardianship or conservatorship
- Pregnant or breastfeeding women
- Patients deprived of their liberty
- Patients not enrolled in the social security system
- Refusal to participate in the study
- Patients receiving immunosuppressive therapy prior to LT (with the exception of corticosteroids at a dosage of 40 mg per day for the treatment of alcoholic hepatitis)
- Patient who is a candidate for a combined organ transplant
- Patient receiving other immunomodulatory therapy (such as immune checkpoint inhibitors) prior to LT
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Patients with severe liver disease waiting for liver transplantation (LT)
Only patients with the most frequent Liver transplantation (LT) indications will be eligible: complicated cirrhosis of hepatocellular carcinoma (HCC), acute or chronic decompensation of cirrhosis, with or without multi-visceral and fulminant hepatitis
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Samples will be collected at the finale inclusion of the day oh the LT, including one sample of Cyto-Chex BCT (4 millilitre mL) .
Same samples will also be collected after LT at days 1,3,5 and 10.
Biological data will be collected at those different times
For the creation of the biobank one samples of Ethylenediaminetetraacetic acid (EDTA) (4 millilitre (mL)), and one PAXgene® sample (2.5mL) will be collected:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Predictive score for the risk of infectious complications
Tidsram: Day 30
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The primary outcome measure will be the diagnostic performance of a predictive score for early post-Liver Transplant (LT) infectious complications occurring within 30 days after LT.
The predictive score will be derived from mHLA-DR levels measured at predefined time points (Day 0, Day 1, Day 3, Day 5, and Day 10 post-LT), the pre-transplant MELD score, and other clinical or laboratory variables significantly associated with infection risk.
The predic
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Day 30
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 69HCL25_1061
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