Decompensation of Cirrhosis and Iron Metabolism

Cirrhosis Clinical Trial

— DeCiFer  

Official title:

Decompensation of Cirrhosis and Iron Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04807023
• Other study ID #: 35RC20_8895_DeCiFer
• Secondary ID: 2020-A02454-35
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: November 2022

Study information

• Verified date: March 2021
• Source: Rennes University Hospital
• Contact: Mevel Nicolas
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Biological:
• blood sampling
blood sampling

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		day 28
Secondary	Serum levels of abnormal iron		days 0, 2, 7 and 14
Secondary	Ceruloplasmin ferroxidase activity		days 0, 2, 7 and 14
Secondary	hepcidin blood levels		days 0, 2, 7 and 14
Secondary	Ferritinemia		days 0, 2, 7 and 14
Secondary	transferrinemia		days 0, 2, 7 and 14
Secondary	transferrin saturation coefficient		days 0, 2, 7 and 14
Secondary	Blood levels of manganese		days 0, 2, 7 and 14
Secondary	Occurrence of complications		during hospitalization and a maximum of 28 days after admission
Secondary	Bacterial infection		during hospitalization and a maximum of 28 days after admission
Secondary	fungal infection		during hospitalization and a maximum of 28 days after admission