Clinical trial NCT04807023: Decompensation of Cirrhosis and Iron Metabolism
Official title: Decompensation of Cirrhosis and Iron Metabolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Keywords: Decompensation of cirrhosis
Iron metabolism
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with diagnosis of cirrhosis hospitalized for acute on chronic liver failure

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: day 28
Secondary outcomes:
measure: Serum levels of abnormal iron
timeFrame: days 0, 2, 7 and 14
measure: Ceruloplasmin ferroxidase activity
timeFrame: days 0, 2, 7 and 14
measure: hepcidin blood levels
timeFrame: days 0, 2, 7 and 14
measure: Ferritinemia
timeFrame: days 0, 2, 7 and 14
measure: transferrinemia
timeFrame: days 0, 2, 7 and 14
measure: transferrin saturation coefficient
timeFrame: days 0, 2, 7 and 14
measure: Blood levels of manganese
timeFrame: days 0, 2, 7 and 14
measure: Occurrence of complications
timeFrame: during hospitalization and a maximum of 28 days after admission
measure: Bacterial infection
timeFrame: during hospitalization and a maximum of 28 days after admission
measure: fungal infection
timeFrame: during hospitalization and a maximum of 28 days after admission
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Giguet Baptiste
role: PRINCIPAL_INVESTIGATOR
References: