This study was designed to compare the safety and efficacy of early continuous renal replacement therapy with standard continuous renal replacement therapy in the presence of acute kidney injury (stage 2 or greater acute kidney injury according to the KDIGO \[The Kidney Disease: Improving Global Outcomes\] classification) in patients with advanced cardiogenic shock on extracorporeal membrane oxygenation.
Patients with cardiogenic shock who are placed on extracorporeal membrane oxygenation devices often have increased afterload due to the retrograde arterial flow of the device, resulting in increased left ventricular filling pressures, and optimal full-load management in these patients may be important to improve prognosis. Previous observational studies have reported that the use of renal replacement therapy for full-load management in patients with cardiogenic shock on extracorporeal membrane oxygenation is effective and improves patient survival in cases of severe renal dysfunction when fluid volume reduction is maintained. However, to date, there have been no randomized controlled studies to identify the optimal timing of renal replacement therapy in patients with cardiogenic shock on extracorporeal membrane oxygenation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
Patients will be randomized to either the standard initiation of the CRRT group or the accelerated initiation of the CRRT group with a 1:1 ratio.
Patients will be randomized to either the standard initiation of the CRRT group or the accelerated initiation of the CRRT group with a 1:1 ratio.
Samsung Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGall-cause mortality or RRT dependence
Time frame: 90 days after patient enrollment
In-hospital mortality
Time frame: Up to 30 days
In-hospital cardiac mortality
Time frame: Up to 30 days
VA-ECMO weaning success
Time frame: Up to 30 days
Time to VA-ECMO weaning
Time frame: Up to 30 days
Critical limb ischemia
Time frame: Up to 30 days
Access site major bleeding
Bleeding Academic Research Consortium \[BARC\] type 3-5
Time frame: Up to 30 days
CPC 3-5
Cerebral Performance Category
Time frame: Up to 30 days
Length of intensive-care unit stay
ICU Stay
Time frame: Up to 30 days
Length of hospital stay
Hospital stay
Time frame: Up to 30 days
Duration of mechanical ventilation
Mechanical Ventilation Maintenance
Time frame: Up to 30 days
Duration of RRT
Renal Replacement Therapy
Time frame: Up to 30 days
all-cause mortality
Time frame: 90 days & 12 months after patient enrollment
cardiac mortality
Time frame: 90 days & 12 months after patient enrollment
Requirement of cardiac replacement therapy
Left ventricular assisted device implantation or heart transplantation
Time frame: 90 days & 12 months after patient enrollment
re-hospitalization due to heart failure
Time frame: 90 days & 12 months after patient enrollment
re-hospitalization due to any cause
Time frame: 90 days & 12 months after patient enrollment
cerebrovascular accident
ischemic or hemorrhagic
Time frame: 90 days & 12 months after patient enrollment
RRT dependence
Time frame: 90 days & 12 months after patient enrollment
Serum creatinine and eGFR
Time frame: 90 days & 12 months after patient enrollment
major bleeding (BARC type 3, or 5)
Time frame: 90 days & 12 months after patient enrollment
clinically meaningful bleeding (BARC type 2, 3, or 5)
Time frame: 90 days & 12 months after patient enrollment
Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion
Time frame: Up to 48 hours
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