Clinical trial NCT06696235: Accelerated Vs. Standard Continuous Renal Replacement Therapy for Patients with Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator
Official title: AcceleRatEd Vs. StandarD ContinUous Renal ReplaCement ThErapy for Patients with Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator: Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cardiogenic Shock
Acute Kidney Injury
Keywords: Extracorporeal Membrane Oxygenator
Cardiogenic Shock
Acute Kidney Injury
Continuous Renal Replacement Therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 408
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Accelerated initiation of CRRT and Standard initiation of CRRT
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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:

1. altered mental status.
2. cold, clammy skin and extremities.
3. oliguria with urine output \< 30ml/h.
4. 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: all-cause mortality or RRT dependence
timeFrame: 90 days after patient enrollment
Secondary outcomes:
measure: In-hospital mortality
timeFrame: Up to 30 days
measure: In-hospital cardiac mortality
timeFrame: Up to 30 days
measure: VA-ECMO weaning success
timeFrame: Up to 30 days
measure: Time to VA-ECMO weaning
timeFrame: Up to 30 days
measure: Critical limb ischemia
timeFrame: Up to 30 days
measure: Access site major bleeding
timeFrame: Up to 30 days
measure: CPC 3-5
timeFrame: Up to 30 days
measure: Length of intensive-care unit stay
timeFrame: Up to 30 days
measure: Length of hospital stay
timeFrame: Up to 30 days
measure: Duration of mechanical ventilation
timeFrame: Up to 30 days
measure: Duration of RRT
timeFrame: Up to 30 days
measure: all-cause mortality
timeFrame: 90 days & 12 months after patient enrollment
measure: cardiac mortality
timeFrame: 90 days & 12 months after patient enrollment
measure: Requirement of cardiac replacement therapy
timeFrame: 90 days & 12 months after patient enrollment
measure: re-hospitalization due to heart failure
timeFrame: 90 days & 12 months after patient enrollment
measure: re-hospitalization due to any cause
timeFrame: 90 days & 12 months after patient enrollment
measure: cerebrovascular accident
timeFrame: 90 days & 12 months after patient enrollment
measure: RRT dependence
timeFrame: 90 days & 12 months after patient enrollment
measure: Serum creatinine and eGFR
timeFrame: 90 days & 12 months after patient enrollment
measure: major bleeding (BARC type 3, or 5)
timeFrame: 90 days & 12 months after patient enrollment
measure: clinically meaningful bleeding (BARC type 2, 3, or 5)
timeFrame: 90 days & 12 months after patient enrollment
measure: Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: