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

April 18, 2023 updated by: Hospices Civils de Lyon

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
        • Not yet recruiting
        • Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
        • Contact:
      • Bron, France, 69500
        • Recruiting
        • Ruste Martin
        • Contact:
          • RUSTE MARTIN, Dr
      • Lyon, France, 69008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: RUSTE Martin, MD, Msc, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Anticipated)

June 15, 2025

Study Completion (Anticipated)

June 16, 2025

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_1013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

Clinical Trials on Continuous renal replacement therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe