Accelerated Vs. Standard Continuous Renal Replacement Therapy for Patients with Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator
- Conditions
- Cardiogenic ShockAcute Kidney Injury
- Registration Number
- NCT06696235
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 408
- The subject must be at least 19 years of age.
- Patients presented with CS (Society for Cardiovascular Angiography and Interventions [SCAI] Shock classification C, D or E) * who requiring VA-ECMO.
- Classic CS (Stage C) was defined as the following criteria. A. Systolic blood pressure less than 90 mmHg for more than 30 min or catecholamines required to maintain pressure more than 90 mmHg during systole. B. Sign of pulmonary congestion
C. Sign of impaired organ perfusion with at least one of the following:
-
altered mental status.
-
cold, clammy skin and extremities.
-
oliguria with urine output < 30ml/h.
-
serum lactate > 2.0 mmol/l.
- SCAI Shock classification D is defined as failure to respond to initial interventions with clinical deterioration of classic CS or SCAI Shock classification E is defined as cardiac arrest with ongoing cardiopulmonary resuscitation requiring VA-ECMO
- Patients in the first 48 hours of CS developing AKI with at least one criterion (Characteristic of the stage 2 AKI according to Kidney Disease: Improving Global Outcomes [KDIGO] classification)
- A 2-fold or over increase in serum creatinine relative to baseline
- A reduction in urine output of ≤0.5 ml/kg/h for ≥ 12 hours
- Other causes of shock (hypovolemia, sepsis, obstructive shock).
- Criteria mandating CRRT initiation: acute kidney injury prior to enrollment caused by any reason, at least one of the following criteria is met.
- serum potassium > 6.5 mmol/L
- serum potassium> 6.0 mmol/L persisting despite medical treatment.
- metabolic acidosis (pH < 7.15 and PaCO2 < 35 mmHg or serum bicarbonate < 12 mmol/L)
- blood urea nitrogen level ≥100 mg/dL.
- diuretics refractory volume overload or pulmonary edema
- Unwitnessed out-of-hospital cardiac arrest with persistent Glasgow coma scale <8 after the return of spontaneous circulation.
- Chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR)<30 mL/min/1.73m2 or end-stage kidney disease under dialysis
- Kidney transplant within the past 365 days
- Receipt of any RRT in the preceding 2 months
- Known heparin intolerance.
- Other severe concomitant disease with limited life expectancy < 6 months
- Pregnancy or breastfeeding
- Do not resuscitate wish.
- Presence of a drug overdose or dialyzable toxin that necessitates RRT.
- Presence or strong clinical suspicion of post-renal AKI duet to obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
- Clinical decision by a responsible physician to immediately start RRT.
- Clinical decision by a responsible physician to defer RRT.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method all-cause mortality or RRT dependence 90 days after patient enrollment
- Secondary Outcome Measures
Name Time Method In-hospital mortality Up to 30 days In-hospital cardiac mortality Up to 30 days VA-ECMO weaning success Up to 30 days Time to VA-ECMO weaning Up to 30 days Critical limb ischemia Up to 30 days Access site major bleeding Up to 30 days Bleeding Academic Research Consortium \[BARC\] type 3-5
CPC 3-5 Up to 30 days Cerebral Performance Category
Length of intensive-care unit stay Up to 30 days ICU Stay
Length of hospital stay Up to 30 days Hospital stay
Duration of mechanical ventilation Up to 30 days Mechanical Ventilation Maintenance
Duration of RRT Up to 30 days Renal Replacement Therapy
all-cause mortality 90 days & 12 months after patient enrollment cardiac mortality 90 days & 12 months after patient enrollment Requirement of cardiac replacement therapy 90 days & 12 months after patient enrollment Left ventricular assisted device implantation or heart transplantation
re-hospitalization due to heart failure 90 days & 12 months after patient enrollment re-hospitalization due to any cause 90 days & 12 months after patient enrollment cerebrovascular accident 90 days & 12 months after patient enrollment ischemic or hemorrhagic
RRT dependence 90 days & 12 months after patient enrollment Serum creatinine and eGFR 90 days & 12 months after patient enrollment major bleeding (BARC type 3, or 5) 90 days & 12 months after patient enrollment clinically meaningful bleeding (BARC type 2, 3, or 5) 90 days & 12 months after patient enrollment Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion Up to 48 hours
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of