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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097784
• Other study ID #: 2013.831
• Secondary ID: 2013-A01622-43
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: July 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cirrhosis
• Diastolic Function
• Fibrosis
• Hepatorenal Syndrome
• Wounds and Injuries

Intervention

Procedure:
• Echocardiography

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
Secondary	Tolerance of volemic expansion, as recommended by international guidelines	Clinical tolerance of volemic expansion, acute pulmonary oedema	After 48 hours of volemic expansion
Secondary	Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome	Renal function recovery, renal replacement therapy, liver transplantation	1 month after inclusion
Secondary	Mortality		1 month after inclusion