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

NCT06696235 | Recruiting Phase 4 DMC

• 1 other identifier: REDUCE-ECMO
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiogenic Shock; Acute Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• all-cause mortality or RRT dependence

  90 days after patient enrollment

Secondary Outcomes (22)

• 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

Study Arms (2)

Accelerated initiation of CRRT

EXPERIMENTAL

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

Standard initiation of CRRT

ACTIVE COMPARATOR

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

Interventions

Early initiation of continuous renal replacement therapy DEVICE

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.

Accelerated initiation of CRRT

Standard initiation of continuous renal replacement therapy DEVICE

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.

Standard initiation of CRRT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jeong Hoon Yang, MD, PhD

CONTACT

82-2-3410-3419; jhysmc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Accelerated initiation of CRRT and Standard initiation of CRRT

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 20, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

KR (2)