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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05209230
Other study ID # 69HCL21_1013
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date June 16, 2025

Study information

Verified date April 2023
Source Hospices Civils de Lyon
Contact RUSTE Martin, MD, Msc
Phone +33472118956
Email martin.ruste@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Myocardial stunning during chronic intermittent hemodialysis is a well-described phenomenon. Little case series of patients presenting myocardial stunning during renal replacement therapy for acute kidney injury in critically ill patients are reported, with intermittent hemodialysis and continuous renal replacement therapy. However, the small sample sizes and the absence of a control arm limit their interpretation, mainly whether the myocardial stunning may be related to cardiac loading conditions variations and whether it may impact the hemodynamic. The investigator hypothesize that myocardial stunning induced by renal replacement therapy is frequent, independent from cardiac loading conditions and associated with peripheral hypoperfusion.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date June 16, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Age > 18 years old - Acute Kidney Injury grade 3 (KDIGO) - Indication for renal replacement therapy for the clinician in charge Exclusion Criteria: - Emergency indication to renal replacement therapy (pH<7.15, Kaliemia > 6mmol/L, refractory pulmonary oedema) - Poor echogenicity with speckle tracking analysis failure - Chronic hemodialysis - Extra corporeal membrane oxygenation, left ventricular assist device.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Continuous renal replacement therapy
Continuous renal replacement therapy (veno venous hemofiltration) without net ultrafiltration, through a dedicated central venous catheter
Other:
Control group
Continuous renal replacement therapy is differed from 6 hours to allowed 2 control echocardiographic evaluations

Locations

Country Name City State
France Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est Bron
France Ruste Martin Bron
France Hopital Edourd Herriot 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 Number of segment of the left ventricle with regional wall motion abnormalities Numbers of segments of the left ventricle (by patient) with a decrease greater than 20% of the peak systolic longitudinal strain (2D speckle tracking) on the second echocardiography as compared to baseline. Change between the echocardiography at baseline and the echocardiography 4 hours after.
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