- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209230
Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients? (MS-CRRT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69008
- Hopital Edourd Herriot
-
-
BRON
-
Bron, BRON, France, 69500
- Ruste Martin
-
-
Bron
-
Bron, Bron, France, 69500
- Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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.
|
Continuous renal replacement therapy is differed from 6 hours to allowed 2 control echocardiographic evaluations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of segment of the left ventricle with regional wall motion abnormalities
Time Frame: 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.
|
Change between the echocardiography at baseline and the echocardiography 4 hours after.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RUSTE Martin, MD, Msc, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Cardiovascular Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Heart Diseases
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Acute Kidney Injury
- Myocardial Stunning
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Therapeutics
- Surgical Procedures, Operative
- Extracorporeal Circulation
- Renal Replacement Therapy
- Control Groups
- Continuous Renal Replacement Therapy
Other Study ID Numbers
- 69HCL21_1013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Stunning
-
Johns Hopkins UniversityMagic That MattersCompletedMyocardial StunningUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...WithdrawnMyocardial Stunning
-
Tampere University HospitalTerminatedMyocardial StunningFinland
-
Tehran University of Medical SciencesRecruitingMyocardial Infarction | Myocardial Ischemia | Myocardial StunningIran, Islamic Republic of
-
Johns Hopkins UniversityWithdrawn
-
University Hospital Inselspital, BerneFederal Office of Sports, SwitzerlandCompletedMyocardial Ischemia | Heart Failure | Exercise | Myocardial Stunning | Myocardial ContractionSwitzerland
-
The First Affiliated Hospital of Dalian Medical...Nanfang Hospital of Southern Medical University; Beijing Anzhen Hospital; First...CompletedHibernation, Myocardial | Complete Occlusion of Coronary Artery
-
Vastra Gotaland RegionRecruiting
-
University Hospital, GenevaWithdrawnMyocardial Stunning | Transesophageal Echocardiography | Circulation, Extracorporeal
-
Vastra Gotaland RegionTerminated
Clinical Trials on Continuous renal replacement therapy
-
Fundacion Clinic per a la Recerca BiomédicaHospital Clinic i provincial de BarcelonaNot yet recruitingContinuous Renal Replacement Therapy (CRRT) | Renal Replacement Therapy for Acute Kidney Injury in ICU
-
Karolinska InstitutetNot yet recruitingCritical Illness | AKI - Acute Kidney Injury
-
University of AlbertaUniversity of Alabama at Birmingham; University of ZagrebNot yet recruitingCritical Illness | Acute Kidney Injury | Renal Dialysis | Continuous Renal Replacement Therapy (CRRT)Canada
-
University of AlbertaRecruitingAcute Kidney Injury | Dialysis; ComplicationsUnited States, Canada, United Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAcute Kidney Injury | ICU Patients | Electrolytes | Continuous Renal Replacement Therapy (CRRT)Spain
-
Sunnybrook Health Sciences CentreDialysis Solutions Inc.Completed
-
Chulalongkorn UniversityCompletedAcute Renal FailureThailand
-
AKI Critical Care Research FoundationUnknownContinuous Renal Replacement TherapyUnited States
-
Southeast University, ChinaCompletedRespiratory Failure With HypercapniaChina
-
Chulalongkorn UniversityCompleted