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NCT Number: NCT06696235

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. all-cause mortality or RRT dependence

    Time frame: 90 days after patient enrollment

Secondary outcomes

  1. In-hospital mortality

    Time frame: Up to 30 days

  2. In-hospital cardiac mortality

    Time frame: Up to 30 days

  3. VA-ECMO weaning success

    Time frame: Up to 30 days

  4. Time to VA-ECMO weaning

    Time frame: Up to 30 days

  5. Critical limb ischemia

    Time frame: Up to 30 days

  6. Access site major bleeding

    Time frame: Up to 30 days

    Bleeding Academic Research Consortium [BARC] type 3-5

  7. CPC 3-5

    Time frame: Up to 30 days

    Cerebral Performance Category

  8. Length of intensive-care unit stay

    Time frame: Up to 30 days

    ICU Stay

  9. Length of hospital stay

    Time frame: Up to 30 days

    Hospital stay

  10. Duration of mechanical ventilation

    Time frame: Up to 30 days

    Mechanical Ventilation Maintenance

  11. Duration of RRT

    Time frame: Up to 30 days

    Renal Replacement Therapy

  12. all-cause mortality

    Time frame: 90 days & 12 months after patient enrollment

  13. cardiac mortality

    Time frame: 90 days & 12 months after patient enrollment

  14. Requirement of cardiac replacement therapy

    Time frame: 90 days & 12 months after patient enrollment

    Left ventricular assisted device implantation or heart transplantation

  15. re-hospitalization due to heart failure

    Time frame: 90 days & 12 months after patient enrollment

  16. re-hospitalization due to any cause

    Time frame: 90 days & 12 months after patient enrollment

  17. cerebrovascular accident

    Time frame: 90 days & 12 months after patient enrollment

    ischemic or hemorrhagic

  18. RRT dependence

    Time frame: 90 days & 12 months after patient enrollment

  19. Serum creatinine and eGFR

    Time frame: 90 days & 12 months after patient enrollment

  20. major bleeding (BARC type 3, or 5)

    Time frame: 90 days & 12 months after patient enrollment

  21. clinically meaningful bleeding (BARC type 2, 3, or 5)

    Time frame: 90 days & 12 months after patient enrollment

  22. Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion

    Time frame: Up to 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jeong Hoon Yang, MD, PhD

CONTACT

[email protected]

82-2-3410-3419

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: REDUCE-ECMO

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Nov 20, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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