Accelerated vs. Standard Continuous Renal Replacement Therapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator

Recruiting now · Phase 4

Conditions studied: Cardiogenic Shock, Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT06696235

Run by

Samsung Medical Center

People needed

408

Starts

2024-12-31

Expected to finish

2029-06-30

Last updated by the study team

2026-01-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Samsung Medical Center — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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