MS-CRRT: Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05209230

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury KDIGO 3 Continuous Renal Replacement Therapy Initiated by the Clinician in Charge Without Emergency Myocardial Stunning	Procedure: Continuous renal replacement therapy Other: Control group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?

Actual Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Jun 15, 2023

Anticipated Study Completion Date :

Jun 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous renal replacement therapy arm Echocardiographic evaluation (with 2D speckle tracking analysis of left ventricular segmental function) 1 hour before and 3 hours after the initiation of continuous renal replacement therapy (continuous veno venous hemofiltration) initiation	Procedure: Continuous renal replacement therapy Continuous renal replacement therapy (veno venous hemofiltration) without net ultrafiltration, through a dedicated central venous catheter
Other: Control arm Two echocardiographic evaluations (with 2D speckle tracking analysis of left ventricular segmental function) at an interval of 4 hours, before the continuous renal replacement therapy initiation.	Other: Control group Continuous renal replacement therapy is differed from 6 hours to allowed 2 control echocardiographic evaluations

Arm

Intervention/Treatment

Experimental: Continuous renal replacement therapy arm

Echocardiographic evaluation (with 2D speckle tracking analysis of left ventricular segmental function) 1 hour before and 3 hours after the initiation of continuous renal replacement therapy (continuous veno venous hemofiltration) initiation

Procedure: Continuous renal replacement therapy

Continuous renal replacement therapy (veno venous hemofiltration) without net ultrafiltration, through a dedicated central venous catheter

Other: Control arm

Two echocardiographic evaluations (with 2D speckle tracking analysis of left ventricular segmental function) at an interval of 4 hours, before the continuous renal replacement therapy initiation.

Other: Control group

Continuous renal replacement therapy is differed from 6 hours to allowed 2 control echocardiographic evaluations

Outcome Measures

Primary Outcome Measures

Number of segment of the left ventricle with regional wall motion abnormalities [Change between the echocardiography at baseline and the echocardiography 4 hours after.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.