Decompensation of Cirrhosis and Iron Metabolism (DeCiFer)

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis
• Intervention / Treatment: Biological: blood sampling

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Mevel Nicolas; Phone Number: 02 99 28 25 55; Email: dri@chu-rennes.fr
• Study Contact Backup: Name: Ganivet Anne; Phone Number: 02 99 28 25 55; Email: anne.ganivet@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: GIGUET Baptiste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum levels of abnormal iron	days 0, 2, 7 and 14
Ceruloplasmin ferroxidase activity	days 0, 2, 7 and 14
hepcidin blood levels	days 0, 2, 7 and 14
Ferritinemia	days 0, 2, 7 and 14
transferrinemia	days 0, 2, 7 and 14
transferrin saturation coefficient	days 0, 2, 7 and 14
Blood levels of manganese	days 0, 2, 7 and 14
Occurrence of complications	during hospitalization and a maximum of 28 days after admission
Bacterial infection	during hospitalization and a maximum of 28 days after admission
fungal infection	during hospitalization and a maximum of 28 days after admission

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Giguet Baptiste, Chu Rennes

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Decompensation of cirrhosis; Iron metabolism
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 35RC20_8895_DeCiFer; 2020-A02454-35 (Other Identifier: N° IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No