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Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT02097784
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Cirrhosis Hepatorenal Syndrome Acute Kidney Injury Diastolic Function Procedure: Echocardiography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Actual Study Start Date : March 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018


Arm Intervention/treatment
cirrhosis with portal hypertension,ascite and acute kidney Procedure: Echocardiography



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Mortality [ Time Frame: 1 month after inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097784


Locations
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France
Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Fanny LEBOSSE, Dr Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02097784    
Other Study ID Numbers: 2013.831
2013-A01622-43 ( Other Identifier: ANSM )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Keywords provided by Hospices Civils de Lyon:
cirrhosis
hepatorenal syndrome
acute kidney injury
diastolic function
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Acute Kidney Injury
Fibrosis
Wounds and Injuries
Pathologic Processes
Liver Diseases
Digestive System Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases