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OpenTrials
Completed

NCT Number: NCT04807023

Decompensation of Cirrhosis and Iron Metabolism

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Biological

blood sampling

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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: DeCiFer

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 19, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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