NCT05209230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

January 11, 2022

Last Update Submit

January 7, 2026

Conditions

Keywords

Acute kidney injury,continuous renal replacement therapymyocardial stunningregional wall motion abnormalities2D speckle tracking echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Continuous renal replacement therapy arm

EXPERIMENTAL

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

Control arm

OTHER

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

Interventions

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

Continuous renal replacement therapy arm

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

Control arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Acute Kidney Injury grade 3 (KDIGO)
  • Indication for renal replacement therapy for the clinician in charge

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est

Bron, Bron, 69500, France

Location

Ruste Martin

Bron, BRON, 69500, France

Location

Hopital Edourd Herriot

Lyon, 69008, France

Location

MeSH Terms

Conditions

Myocardial StunningAcute Kidney Injury

Interventions

Continuous Renal Replacement TherapyControl Groups

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, OperativeEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • RUSTE Martin, MD, Msc

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 26, 2022

Study Start

April 15, 2022

Primary Completion

December 18, 2025

Study Completion

December 18, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations