- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097784
Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
March 8, 2019 updated by: Hospices Civils de Lyon
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69004
- Hospices Civils de Lyon - Hôpital de la Croix-Rousse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: cirrhosis with portal hypertension,ascite and acute kidney
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerance of volemic expansion, as recommended by international guidelines
Time Frame: After 48 hours of volemic expansion
|
Clinical tolerance of volemic expansion, acute pulmonary oedema
|
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
|
Renal function recovery, renal replacement therapy, liver transplantation
|
1 month after inclusion
|
Mortality
Time Frame: 1 month after inclusion
|
1 month after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fanny LEBOSSE, Dr, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2014
Primary Completion (ACTUAL)
July 1, 2018
Study Completion (ACTUAL)
July 1, 2018
Study Registration Dates
First Submitted
March 24, 2014
First Submitted That Met QC Criteria
March 24, 2014
First Posted (ESTIMATE)
March 27, 2014
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013.831
- 2013-A01622-43 (OTHER: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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