Early dialysis for shock patients on ECMO: could it save more lives?
NCT ID NCT06696235
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is for adults with severe cardiogenic shock who need a heart-lung machine (ECMO) and have developed acute kidney injury. Researchers want to see if starting dialysis (continuous renal replacement therapy) earlier improves survival and reduces long-term kidney dependence. About 408 participants will be randomly assigned to either early or standard dialysis timing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- continuous renal replacement therapy (a type of dialysis)
- What this could lead to
- If early dialysis proves better, it could become the new standard for protecting kidney function and reducing deaths in these critically ill patients.
- What could go wrong
- This is a single-center trial in South Korea, so results may not apply everywhere. Early dialysis also carries risks like bleeding or infection from the access line.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 408 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Samsung Medical Center
NOT_YET_RECRUITINGSeoul, South Korea
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