Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT06696235
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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06696235
Study Brief:
Protocol Section:
NCT06696235