Decompensation of Cirrhosis and Iron Metabolism

NCT ID: NCT04807023

Last Updated: 2021-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2022-11-30

Brief Summary

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Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.

A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.

Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.

Detailed Description

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Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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blood sampling

blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old.
* Diagnosis of cirrhosis, previously known or not, of any etiology, histologically proven or not.
* Hospitalization for acute on chronic liver failure:
* Ascites decompensation.
* Or spontaneous infection of the ascites fluid (defined as PNN \> 250/mm3 of ascites).
* Or digestive hemorrhage related to portal hypertension (digestive fibroscopy showing active bleeding or stigmas of recent bleeding from esophageal and/or gastric varices).
* Or hepatic encephalopathy (clinically defined +/- increase in ammonia and/or by electroencephalogram and classified in stages according to West-Haven).
* Or hepato-renal syndrome (HRS-AKI criteria, EASL 2018).
* Or bacterial infection (defined by a bacteremia identified by at least one blood culture and/or an infectious site authenticated on imaging).
* Or Acute Alcoholic Hepatitis (histologically proven or not).
* Non-opposition of the patient, relative or legal representative.

Exclusion Criteria

* Treatment with oral or intravenous iron in the month prior to hospitalization.
* Implementation of a TIPS in the month prior to admission.
* Presence of hepatocellular carcinoma with an expected survival \< 3 months or any other progressive cancer.
* Adult person subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giguet Baptiste

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

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CHU Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mevel Nicolas

Role: CONTACT

02 99 28 25 55

Ganivet Anne

Role: CONTACT

02 99 28 25 55

Facility Contacts

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GIGUET Baptiste

Role: primary

Other Identifiers

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2020-A02454-35

Identifier Type: OTHER

Identifier Source: secondary_id

35RC20_8895_DeCiFer

Identifier Type: -

Identifier Source: org_study_id

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NASH and Coronary Disease
NCT03819283 UNKNOWN NA