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Characterization of Metabolomic Fingerprints in Patients With Acute Liver Failure and Acute-on-chronic Liver Failure With Hepatic Encephalopathy

NCT05772585 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-08-01

No results posted yet for this study

Summary

Hepatic encephalopathy is a frequent complication of both acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) and could be responsible among other neurological complications of residual impairment after liver transplantation. Specific metabolomic studies have shed light into pathophysiology. Nevertheless, whether HE metabolomic fingerprints differ between HE in ALF and HE in ACLF and their evolution after liver transplantation (LT) is unknown.

The aim of our study is to analyse the metabolomic fingerprint in plasma of 2 different groups of patients before and after LT:

* hospitalized patients with ALF and HE
* hospitalized patients with ACLF and HE We will analyse metabolomic results to explore if there is any difference in metabolomic fingerprints between these 2 groups and if LT modify the metabolomic fingerprint in plasma in these 2 groups and in the same way.

We will collect blood samples in these 2 groups on the day of HE occurring and then on day 1, day 7 and day 30 (+/- 2 days) after LT. We aim to enroll 10 patients in ALF group and 20 patients in ACLF group.

Inclusion criteria are defined as age \> 18 years, patient presenting with ALF (Synthetic liver failure (INR \> 1.5) with hepatic encephalopathy (grade 1-4 of West-Haven classification), without pre-existing hepatopathy, HE beginning within \<26 weeks) or ACLF (≥ grade 1 from CANONIC criteria), and clinical HE (grade 1-4 of West-Haven classification) on the day of enrolment. Exclusion criteria are defined as age \< 18 years, absence of HE, LT without pre-existing HE, patients who already undergone a LT, legally protected person.

An EDTA blood sample will be collected, centrifuged and frozen on the day of enrolment, then on day 1, day 7 and day 30 (+/- 2 days) after LT. Metabolomic analyses will be performed by different techniques but especially with high resolution liquid phase mass spectrometry in collaboration with CEA. Statistical analyses will be both univariate (Mann-Whitney or Wilcoxon tests) and multivariate (with a classical and adapted method for metabolomic studies: Partial Least-Squares Discriminant Analysis (PLS-DA)).

We expect to identify different metabolomic fingerprints between HE in both ALF and ACLF patients as well as different kinetics for symptoms resolution after LT. The long-term objective is to target the specific metabolic pathways for each group in order to allow development of new targeted drugs against HE in these 2 different conditions.

Conditions

  • Hepatic Encephalopathy
  • Acute Liver Failure
  • Acute on Chronic Liver Failure

Interventions

OTHER

Blood collection

Blood collection (1 to 4 times for each patient) in order to perform metabolomic analyses of the plasmatic fingerprints of patients with hepatic encephalopathy

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicolas WEISS, MD, PhD · APHP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-04-30
Completion
2024-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05772585 on ClinicalTrials.gov