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

Primary Purpose

Acute Kidney Injury KDIGO 3, Continuous Renal Replacement Therapy Initiated by the Clinician in Charge Without Emergency, Myocardial Stunning

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous renal replacement therapy
Control group
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Kidney Injury KDIGO 3 focused on measuring Acute kidney injury,, continuous renal replacement therapy, myocardial stunning, regional wall motion abnormalities, 2D speckle tracking echocardiography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
  • Ruste MartinRecruiting
  • Hopital Edourd HerriotRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Continuous renal replacement therapy arm

Control arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2022
Last Updated
April 18, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05209230
Brief Title
Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?
Acronym
MS-CRRT
Official Title
Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury KDIGO 3, Continuous Renal Replacement Therapy Initiated by the Clinician in Charge Without Emergency, Myocardial Stunning
Keywords
Acute kidney injury,, continuous renal replacement therapy, myocardial stunning, regional wall motion abnormalities, 2D speckle tracking echocardiography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous renal replacement therapy arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Continuous renal replacement therapy
Intervention Description
Continuous renal replacement therapy (veno venous hemofiltration) without net ultrafiltration, through a dedicated central venous catheter
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Continuous renal replacement therapy is differed from 6 hours to allowed 2 control echocardiographic evaluations
Primary Outcome Measure Information:
Title
Number of segment of the left ventricle with regional wall motion abnormalities
Description
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.
Time Frame
Change between the echocardiography at baseline and the echocardiography 4 hours after.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RUSTE Martin, MD, Msc
Phone
+33472118956
Email
martin.ruste@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
JACQUET-LAGREZE Matthias, MD, Msc
Email
Matthias.jacquet-lagreze@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUSTE Martin, MD, Msc
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RUSTE Martin, MD, Msc
Phone
+33472118956
Email
martin.ruste@gmail.com
Facility Name
Ruste Martin
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RUSTE MARTIN, Dr
Facility Name
Hopital Edourd Herriot
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CROZON-CLAUZEL Jullien, Dr
Email
jullien.crozon-clauzel@chu-lyon.fr

12. IPD Sharing Statement

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

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