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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jhysmc@gmail.com
• Phone: 82-2-3410-3419

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.