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

NCT02097784 | Completed

• 2 other identifiers: 2013.8312013-A01622-43
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hepatorenal Syndrome; Acute Kidney Injury; Diastolic Function

Keywords

cirrhosis; hepatorenal syndrome; acute kidney injury; diastolic function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tolerance of volemic expansion, as recommended by international guidelines

  After 48 hours of volemic expansion

• Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome

  1 month after inclusion

• Mortality

  1 month after inclusion

Study Arms (1)

cirrhosis with portal hypertension,ascite and acute kidney

OTHER

Procedure: Echocardiography

Interventions

Echocardiography PROCEDURE

cirrhosis with portal hypertension,ascite and acute kidney

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Fibrosis; Hepatorenal Syndrome; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Study Officials

• Fanny LEBOSSE, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 27, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)