Actively Recruiting
Accelerated vs Standard Continuous Renal Replacement Therapy for Patients With Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Trial
Led by Samsung Medical Center · Updated on 2026-01-05
408
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of early versus standard continuous renal replacement therapy (CRRT) in patients with advanced cardiogenic shock who develop acute kidney injury (stage 2 or higher) while on veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This trial aims to determine the best timing for starting CRRT to improve outcomes in this critically ill population, as previous observational studies have suggested benefits but no randomized trials have confirmed optimal timing. Participants will be randomly assigned to one of two groups: an accelerated group where CRRT starts as soon as possible and within 6 hours after meeting eligibility, and a standard group where CRRT begins only if certain clinical criteria develop, such as severe potassium imbalance, metabolic acidosis, high blood urea nitrogen, or refractory fluid overload. These approaches will be compared to assess their impact on patient outcomes during the study period. During the trial, participants will be monitored for various clinical outcomes including mortality, dependence on renal replacement therapy at 90 days, successful weaning from VA-ECMO, bleeding events, duration of intensive care, and other complications. The study includes assessments up to 12 months after enrollment to track longer-term outcomes. Data collection involves clinical evaluations, laboratory tests, and monitoring of organ function over time to understand the effects of CRRT timing on recovery and survival.
CONDITIONS
Brief Title
Accelerated vs. Standard Continuous Renal Replacement Therapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years of age
- Diagnosed with cardiogenic shock (SCAI Shock classification C, D, or E) requiring veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
- Classic cardiogenic shock defined by low systolic blood pressure, signs of pulmonary congestion, and organ perfusion impairment
- Acute kidney injury stage 2 or higher within 48 hours of cardiogenic shock onset, defined by KDIGO criteria including increased serum creatinine or reduced urine output
You will not qualify if you...
- Shock caused by hypovolemia, sepsis, or obstruction
- Acute kidney injury prior to enrollment meeting criteria such as severe hyperkalemia, metabolic acidosis, or high blood urea nitrogen
- Unwitnessed out-of-hospital cardiac arrest with poor neurological status
- Chronic kidney disease with eGFR less than 30 mL/min/1.73m2 or dialysis dependence
- Kidney transplant within the past year
- Recent receipt of renal replacement therapy within 2 months
- Known intolerance to heparin
- Severe other diseases limiting life expectancy to less than 6 months
- Pregnancy or breastfeeding
- Do not resuscitate order
- Drug overdose or toxin requiring renal replacement therapy
- Post-renal acute kidney injury suspicion or related disorders
- Immediate clinical decision to start or defer renal replacement therapy by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive either accelerated or standard initiation of continuous renal replacement therapy while undergoing veno-arterial extracorporeal membrane oxygenation for cardiogenic shock.
Daily visits during therapy period
Duration - Up to 12 months
Participants are monitored for outcomes including mortality, renal replacement therapy dependence, and rehospitalization up to 12 months after enrollment.
Periodic visits up to 12 months
Trial Site Locations
Total: 2 locations
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
Research Team
J
Jeong Hoon Yang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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