Early versus standard continuous dialysis for adults with cardiogenic shock on VA‑ECMO

AcceleRatEd vs. StandarD ContinUous Renal ReplaCement ThErapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator: Randomized-Controlled Trial

We will test whether starting continuous dialysis earlier helps adults with cardiogenic shock and moderate-to-severe acute kidney injury who are on veno-arterial ECMO, compared with the usual timing.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 408 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (Academic / other)
• Locations: 2 sites (Seoul and 1 other locations)
• Trial ID: NCT06696235 on ClinicalTrials.gov

What this trial studies

This randomized phase 4 trial at Samsung Medical Center compares early versus standard initiation of continuous renal replacement therapy (CRRT) in adults with cardiogenic shock on veno-arterial extracorporeal membrane oxygenation (VA‑ECMO) who develop KDIGO stage 2 or greater acute kidney injury within 48 hours. Participants are assigned to either early CRRT or standard-timed CRRT and are followed for safety and efficacy endpoints such as fluid balance, organ function, and survival. Eligible patients meet SCAI shock stages C–E and are at least 19 years old. The trial aims to establish whether earlier CRRT for load management improves hemodynamics and clinical outcomes compared with current practice.

Who should consider this trial

Good fit: Adults (≥19 years) with cardiogenic shock requiring VA‑ECMO who develop KDIGO stage 2 or greater acute kidney injury within the first 48 hours are the ideal candidates.

Not a fit: Patients without significant AKI, those not supported with VA‑ECMO, or those with contraindications to CRRT are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, earlier CRRT could reduce fluid overload, lower left ventricular filling pressures, and improve organ perfusion and survival in VA‑ECMO patients with AKI.

How similar studies have performed: Observational studies have reported improved survival and fluid management with RRT in ECMO patients, but randomized controlled evidence on timing is currently lacking.

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.

Where this trial is running

Seoul and 1 other locations

• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Not_yet_recruiting)

Study contacts

• Study coordinator: Jeong Hoon Yang, MD, PhD

Conditions Cardiogenic Shock; Acute Kidney Injury; Extracorporeal Membrane Oxygenator; Continuous Renal Replacement Therapy