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Decompensation of Cirrhosis and Iron Metabolism

Decompensation of Cirrhosis and Iron Metabolism

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04807023
Acronym
DeCiFer
Enrollment
98
Registered
2021-03-19
Start date
2021-09-08
Completion date
2025-09-20
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

Decompensation of cirrhosis, Iron metabolism

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.

Interventions

BIOLOGICALblood sampling

blood sampling

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Mortalityday 28

Secondary

MeasureTime frame
Serum levels of abnormal irondays 0, 2, 7 and 14
Ceruloplasmin ferroxidase activitydays 0, 2, 7 and 14
hepcidin blood levelsdays 0, 2, 7 and 14
Ferritinemiadays 0, 2, 7 and 14
transferrinemiadays 0, 2, 7 and 14
transferrin saturation coefficientdays 0, 2, 7 and 14
Blood levels of manganesedays 0, 2, 7 and 14
Occurrence of complicationsduring hospitalization and a maximum of 28 days after admission
Bacterial infectionduring hospitalization and a maximum of 28 days after admission
fungal infectionduring hospitalization and a maximum of 28 days after admission

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGiguet Baptiste

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026