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New treatment option for Cardiogenic Shock
Official title Accelerated vs. Standard Continuous Renal Replacement Therapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator
ClinicalTrials.gov ID: NCT06696235
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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...
- altered mental status.
- cold, clammy skin and extremities.
You likely can't join 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.
See the full eligibility 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...
- 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.