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

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• all-cause mortality or RRT dependence [Time frame: 90 days after patient enrollment]

Secondary outcome measures (12)

• In-hospital mortality [Time frame: Up to 30 days]
• In-hospital cardiac mortality [Time frame: Up to 30 days]
• VA-ECMO weaning success [Time frame: Up to 30 days]
• Time to VA-ECMO weaning [Time frame: Up to 30 days]
• Critical limb ischemia [Time frame: Up to 30 days]
• Access site major bleeding [Time frame: Up to 30 days]
• CPC 3-5 [Time frame: Up to 30 days]
• Length of intensive-care unit stay [Time frame: Up to 30 days]
• Length of hospital stay [Time frame: Up to 30 days]
• Duration of mechanical ventilation [Time frame: Up to 30 days]
• Duration of RRT [Time frame: Up to 30 days]
• all-cause mortality [Time frame: 90 days & 12 months after patient enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

South Korea · 2 centers

• Samsung Medical Center — Seoul
• Samsung Medical Center — Seoul

Identifiers

NCT: NCT06696235 · REDUCE-ECMO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗