Metobolomics in the Characterisation of HE

Cirrhosis Clinical Trial

— METABO-EH  

Official title:

Characterization of Metabolomic Fingerprints in Patients With Hepatic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06245473
• Other study ID #: APHP220279
• Status: Recruiting
• Start date: April 23, 2024
• Est. completion date: April 23, 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marika Rudler, MD, PhD
• Phone: +33142161454
• Email: marika.rudler[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatic encephalopathy is (HE) defined by the neurological and/or neuropsychological symptoms caused by an acute or chronic liver disease and/or a portosystemic shunt. Its pathophysiology is still debated, although the synergic role of hyperammonemia and inflammation is now admitted for years. Several additional mechanisms have been suspected, one of them being an altered permeability of the brain blood barrier (BBB). Nevertheless, many aspects remain poorly understood.

The rise of "-omics" techniques, and especially metabolomics, allowed to identify more precisely the different metabolic pathways that are involved in the pathophysiology of HE. Using a high flow chemistry technique and multivariate data analysis, metabolomics is an accurate way to understand the pathophysiology and pathogenesis of multifactorial diseases such as HE. Several studies have been published in cirrhosis. It has been suggested that serum metabolites at admission, as well as thyroxine, can predict advanced HE in patients without brain failure. In a cohort including more than 600 patients, a higher microbially-derived metabolites, together with a lower thyroxine level, were associated with further development of brain failure. In another study from the same team, serum and urinary metabolites were significantly different in hospitalised patients who had developed poor outcome or not. Another study conducted in the CANONIC cohort as also found changes in metabolites of patients with cirrhosis and acute-on-chronic liver failure (ACLF), revealing mitochondrial dysfunction in peripheral organs that may contribute to organ failures. Last, our team previously analysed plasma and cerebrospinal fluid (CSF) samples of patients with cirrhosis and HE hospitalised in intensive care unit (ICU), showing alteration in ammonia and amino-acids metabolism, and also in energy metabolism. However, in the latest study, ALCF grading was not available. As many of these patients were in a severe condition, one could hypothesize that the metabolomic changes observed in these patients may have been confounded by an ACLF profile. Therefore, the objective of this study is to characterize the metabolomic fingerprints of HE in patients with cirrhosis, using 4 different groups of patients: patients with or without HE, with or without ALCF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 23, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged = 18 years

• Patient with cirrhosis of any etiology

• Informed patient who does not object to participating in the study

• Patient affiliated to a social security scheme or entitled beneficiary

Exclusion Criteria:

• Pregnant or breast-feeding women

• Protected populations: under guardianship or trusteeship

• Previous liver transplant

• Patient on AME

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy

Intervention

Diagnostic Test:
• blood sample
During the blood test planned as part of the care an additional blood tube with a volume of 6mL will be taken´ in an EDTA tube.

Locations

Country	Name	City	State
France	Service d'hépato-gastroentérologie Hôpital Pitié Salpêtrière	Paris
France	Sorbonne University, Pitié salpêtrière hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolomic analysis by mass spectrometry from a 6mL blood sample of cirrhotic patients.		At the inclusion visit