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Early dialysis for shock patients on ECMO: could it save more lives?

NCT ID NCT06696235

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 408 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Samsung Medical Center

    NOT_YET_RECRUITING

    Seoul, South Korea

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