NCT04807023

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 19, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 16, 2021

Last Update Submit

July 13, 2021

Conditions

Cirrhosis

Keywords

Decompensation of cirrhosisIron metabolism

Outcome Measures

Primary Outcomes (1)

  • Mortality

    day 28

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Interventions

blood samplingBIOLOGICAL

blood sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Giguet Baptiste

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mevel Nicolas

CONTACT

02 99 28 25 55dri@chu-rennes.fr

Ganivet Anne

CONTACT

02 99 28 25 55anne.ganivet@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

May 17, 2021

Primary Completion

May 1, 2022

Study Completion

November 1, 2022

Last Updated

July 19, 2021

Record last verified: 2021-03

Locations

FR(1)