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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Cardiogenic Shock
• Intervention / Treatment: Device: Early initiation of continuous renal replacement therapy; Device: Standard initiation of continuous renal replacement therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeong Hoon Yang, MD, PhD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Ki Hong Choi; Phone Number: 01088751648; Email: cardiokh@gmail.com
  • Seoul, South Korea
    • Not yet recruiting
    • Samsung Medical Center
    • Contact: Jeong Hoon Yang, MD, PhD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com
    • Contact: Ki Hong Choi, MD, PhD; Email: cardiokh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accelerated initiation of CRRT; In the accelerated-strategy group, RRT is initiated as soon as possible and within 6 hours after patients have met full eligibility criteria.	Device: Early initiation of continuous renal replacement therapy; Patients will be randomized to either the standard initiation of the CRRT group or the accelerated initiation of the CRRT group with a 1:1 ratio.
Active Comparator: Standard initiation of CRRT; Clinicians were discouraged from initiating RRT until the development of one or more of the following criteria.; 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; Oliguria (≤0.3 ml/kg/hour) or anuria for 48h or more; Diuretics refractory fluid overload or pulmonary edema	Device: Standard initiation of continuous renal replacement therapy; Patients will be randomized to either the standard initiation of the CRRT group or the accelerated initiation of the CRRT group with a 1:1 ratio.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality or RRT dependence	90 days after patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality		Up to 30 days
In-hospital cardiac mortality		Up to 30 days
VA-ECMO weaning success		Up to 30 days
Time to VA-ECMO weaning		Up to 30 days
Critical limb ischemia		Up to 30 days
Access site major bleeding	Bleeding Academic Research Consortium [BARC] type 3-5	Up to 30 days
CPC 3-5	Cerebral Performance Category	Up to 30 days
Length of intensive-care unit stay	ICU Stay	Up to 30 days
Length of hospital stay	Hospital stay	Up to 30 days
Duration of mechanical ventilation	Mechanical Ventilation Maintenance	Up to 30 days
Duration of RRT	Renal Replacement Therapy	Up to 30 days
all-cause mortality		90 days & 12 months after patient enrollment
cardiac mortality		90 days & 12 months after patient enrollment
Requirement of cardiac replacement therapy	Left ventricular assisted device implantation or heart transplantation	90 days & 12 months after patient enrollment
re-hospitalization due to heart failure		90 days & 12 months after patient enrollment
re-hospitalization due to any cause		90 days & 12 months after patient enrollment
cerebrovascular accident	ischemic or hemorrhagic	90 days & 12 months after patient enrollment
RRT dependence		90 days & 12 months after patient enrollment
Serum creatinine and eGFR		90 days & 12 months after patient enrollment
major bleeding (BARC type 3, or 5)		90 days & 12 months after patient enrollment
clinically meaningful bleeding (BARC type 2, 3, or 5)		90 days & 12 months after patient enrollment
Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion		Up to 48 hours

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Actual): November 20, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Cardiogenic Shock; Continuous Renal Replacement Therapy; Extracorporeal Membrane Oxygenator
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Infarction; Necrosis; Renal Insufficiency; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Acute Kidney Injury; Shock, Cardiogenic
• Other Study ID Numbers: REDUCE-ECMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No