CirrhosisCIRRENNCT02097784
Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
A study testing Echocardiography in people with Cirrhosis and Hepatorenal Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatorenal Syndrome, Acute Kidney Injury
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- patients > 18 years
- written consent for the participation of the study
- cirrhosis with portal hypertension and ascite
- acute kidney injury according to AKIN criteria (rapid increase of creatinine (48 hours) > 26.4 µmol or > 50% comparing with baseline). Baseline creatinine is the last value of creatinine before admission or creatinine at the admission if stable during 5 days.
- absence of argument for acute tubular necrosis or other organic acute renal injury
- absence of argument for shock
Who cannot join
- pregnant women
- volemic expansion before echocardiography
- portal thrombosis
- presence of TIPSS
- history of cardiac or renal pathology
- atrial fibrillation
- cardiac valvulopathy
- technical limitation due to echogenicity
Trial locations and contacts
1 site in 1 country.
About this study
This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe the hemodynamic characteristics of this population at the time of acute kidney injury and their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of the study after the echocardiography and will not undergo volemic expansion but appropriate management.
- Being tested
- Echocardiography
- Keywords
- cirrhosis, hepatorenal syndrome, acute kidney injury, diastolic function
- Medical subject headings
- Fibrosis, Hepatorenal Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| cirrhosis with portal hypertension,ascite and acute kidney | Other | Not described Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic features assessed by echocardiography before the volemic expansion of cirrhotic patients with acute renal injury corresponding to the criteria of hepatorenal syndrome.
Systolic and diastolic function assessment, filling pressures, pulmonary arterial hypertension
Measured: At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
Secondary outcomes (3)
Tolerance of volemic expansion, as recommended by international guidelines
Clinical tolerance of volemic expansion, acute pulmonary oedema
Measured: After 48 hours of volemic expansion
Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome
Renal function recovery, renal replacement therapy, liver transplantation
Measured: 1 month after inclusion
Mortality
Measured: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2018
- Study completionJul 2018
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 Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny LEBOSSE, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097784
- Sponsor's protocol ID
- 2013.831
- Other IDs
- 2013-A01622-43
- Acronym
- CIRREN
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2014
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02097784
- Acronym / sponsor ID
- CIRREN / 2013.831
- Keywords
- cirrhosis, hepatorenal syndrome, acute kidney injury, diastolic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Mar 2014 (estimated)
- 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.
This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe the hemodynamic characteristics of this population at the time of acute kidney injury and their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of the study after the echocardiography and will not undergo volemic expansion but appropriate management.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhosis with portal hypertension,ascite and acute kidney | Other | Procedure: Echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients > 18 years
- written consent for the participation of the study
- cirrhosis with portal hypertension and ascite
- acute kidney injury according to AKIN criteria (rapid increase of creatinine (48 hours) > 26.4 µmol or > 50% comparing with baseline). Baseline creatinine is the last value of creatinine before admission or creatinine at the admission if stable during 5 days.
- absence of argument for acute tubular necrosis or other organic acute renal injury
Key exclusion criteria (8 listed)
- pregnant women
- volemic expansion before echocardiography
- portal thrombosis
- presence of TIPSS
- history of cardiac or renal pathology
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 |
|---|---|---|
| Echocardiography | Procedure or surgery | cirrhosis with portal hypertension,ascite and acute kidney |
Primary outcome
Hemodynamic features assessed by echocardiography before the volemic expansion of cirrhotic patients with acute renal injury corresponding to the criteria of hepatorenal syndrome.
Time frame: At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
Systolic and diastolic function assessment, filling pressures, pulmonary arterial hypertension
3 secondary outcomes
Tolerance of volemic expansion, as recommended by international guidelines
Time frame: After 48 hours of volemic expansion
Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome
Time frame: 1 month after inclusion
Mortality
Time frame: 1 month after inclusion
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 19 Dec 2025.
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Fanny LEBOSSE, Dr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography in people with Cirrhosis and Hepatorenal Syndrome, run by Hospices Civils de Lyon 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 6 inclusion and 8 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 19 Dec 2025. 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?
Hemodynamic features assessed by echocardiography before the volemic expansion of cirrhotic patients with acute renal injury corresponding to the criteria of hepatorenal syndrome. (time frame: At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.). 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 19 Dec 2025.