CirrhosisDeCiFerNCT04807023
Decompensation of Cirrhosis and Iron Metabolism
An observational study of Cirrhosis, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- blood sampling
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2021to 20 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with diagnosis of cirrhosis hospitalized for acute on chronic liver failure
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cirrhosis
- Being tested
- blood sampling
- Keywords
- Decompensation of cirrhosis, Iron metabolism
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
blood sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: day 28
Secondary outcomes (10)
Serum levels of abnormal iron
Measured: days 0, 2, 7 and 14
Ceruloplasmin ferroxidase activity
Measured: days 0, 2, 7 and 14
hepcidin blood levels
Measured: days 0, 2, 7 and 14
Ferritinemia
Measured: days 0, 2, 7 and 14
transferrinemia
Measured: days 0, 2, 7 and 14
transferrin saturation coefficient
Measured: days 0, 2, 7 and 14
Blood levels of manganese
Measured: days 0, 2, 7 and 14
Occurrence of complications
Measured: during hospitalization and a maximum of 28 days after admission
Bacterial infection
Measured: during hospitalization and a maximum of 28 days after admission
fungal infection
Measured: during hospitalization and a maximum of 28 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start8 Sep 2021
- Primary completion20 Sep 2024
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giguet Baptiste, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807023
- Sponsor's protocol ID
- 35RC20_8895_DeCiFer
- Other IDs
- 2020-A02454-35
- Acronym
- DeCiFer
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompensation of Cirrhosis and Iron Metabolism
- ClinicalTrials.gov ID
- NCT04807023
- Acronym / sponsor ID
- DeCiFer / 35RC20_8895_DeCiFer
- Conditions
- Cirrhosis
- Keywords
- Decompensation of cirrhosis, Iron metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with diagnosis of cirrhosis hospitalized for acute on chronic liver failure
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingblood sampling | Biological | – |
Primary outcome
Mortality
Time frame: day 28
10 secondary outcomes
Serum levels of abnormal iron
Time frame: days 0, 2, 7 and 14
Ceruloplasmin ferroxidase activity
Time frame: days 0, 2, 7 and 14
hepcidin blood levels
Time frame: days 0, 2, 7 and 14
Ferritinemia
Time frame: days 0, 2, 7 and 14
transferrinemia
Time frame: days 0, 2, 7 and 14
transferrin saturation coefficient
Time frame: days 0, 2, 7 and 14
Blood levels of manganese
Time frame: days 0, 2, 7 and 14
Occurrence of complications
Time frame: during hospitalization and a maximum of 28 days after admission
Bacterial infection
Time frame: during hospitalization and a maximum of 28 days after admission
fungal infection
Time frame: during hospitalization and a maximum of 28 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giguet Baptiste principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.