Back to resultsInterest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Primary Purpose
Cirrhosis, Hepatorenal Syndrome, Acute Kidney Injury
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Cirrhosis focused on measuring cirrhosis, hepatorenal syndrome, acute kidney injury, diastolic function
Eligibility Criteria
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
Sites / Locations
- Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
cirrhosis with portal hypertension,ascite and acute kidney
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Tolerance of volemic expansion, as recommended by international guidelines
Clinical tolerance of volemic expansion, acute pulmonary oedema
Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome
Renal function recovery, renal replacement therapy, liver transplantation
Mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02097784
Brief Title
Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Official Title
Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hepatorenal Syndrome, Acute Kidney Injury, Diastolic Function
Keywords
cirrhosis, hepatorenal syndrome, acute kidney injury, diastolic function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cirrhosis with portal hypertension,ascite and acute kidney
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Primary Outcome Measure Information:
Title
Hemodynamic features assessed by echocardiography before the volemic expansion of cirrhotic patients with acute renal injury corresponding to the criteria of hepatorenal syndrome.
Description
Systolic and diastolic function assessment, filling pressures, pulmonary arterial hypertension
Time Frame
At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
Secondary Outcome Measure Information:
Title
Tolerance of volemic expansion, as recommended by international guidelines
Description
Clinical tolerance of volemic expansion, acute pulmonary oedema
Time Frame
After 48 hours of volemic expansion
Title
Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome
Description
Renal function recovery, renal replacement therapy, liver transplantation
Time Frame
1 month after inclusion
Title
Mortality
Time Frame
1 month after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny LEBOSSE, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
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