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CompletedNCT04807023DeCiFerUpdated Jun 12, 2026

Decompensation of Cirrhosis and Iron Metabolism

An observational study in Cirrhosis, sponsored by Rennes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Cirrhosis

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Keywords

  • Decompensation of cirrhosis
  • Iron metabolism
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's enrollment of 98 is below the median of 110 across 973 observational studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with diagnosis of cirrhosis hospitalized for acute on chronic liver failure

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No

Interventions

  • Biologicalblood sampling

    blood sampling

06

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: day 28

Secondary outcomes

  1. Serum levels of abnormal iron

    Time frame: days 0, 2, 7 and 14

  2. Ceruloplasmin ferroxidase activity

    Time frame: days 0, 2, 7 and 14

  3. hepcidin blood levels

    Time frame: days 0, 2, 7 and 14

  4. Ferritinemia

    Time frame: days 0, 2, 7 and 14

  5. transferrinemia

    Time frame: days 0, 2, 7 and 14

  6. transferrin saturation coefficient

    Time frame: days 0, 2, 7 and 14

  7. Blood levels of manganese

    Time frame: days 0, 2, 7 and 14

  8. Occurrence of complications

    Time frame: during hospitalization and a maximum of 28 days after admission

  9. Bacterial infection

    Time frame: during hospitalization and a maximum of 28 days after admission

  10. fungal infection

    Time frame: during hospitalization and a maximum of 28 days after admission

07

Study locations

1 site
  • CHU Rennes
    Rennes, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04807023
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Sep 8, 2021
Primary completion
Sep 20, 2024
Completion
Sep 20, 2025
Last update
Jun 12, 2026

Study contacts

Giguet Baptiste
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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