Cardiogenic ShockPhase 4REDUCE-ECMONCT06696235
Accelerated vs. Standard Continuous Renal Replacement Therapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator
A Phase 4 study testing Early initiation of continuous renal replacement therapy and Standard initiation of continuous renal replacement therapy in people with Cardiogenic Shock and Acute Kidney Injury, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
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]… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Kidney Injury
- What is being tested?
- Early initiation of continuous renal replacement therapy and Standard initiation of continuous renal replacement therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 31 Dec 2024to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Sign of impaired organ perfusion with at least one of the following:
- altered mental status.
- cold, clammy skin and extremities.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Ki Hong Choi, 01088751648, cardiokh@gmail.com
- Not yet recruiting
Samsung Medical Center
Seoul
Jeong Hoon Yang, MD, PhD, 82-2-3410-3419, jhysmc@gmail.com
Ki Hong Choi, MD, PhD, cardiokh@gmail.com
About this study
Official title: AcceleRatEd vs. StandarD ContinUous Renal ReplaCement ThErapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator: Randomized-Controlled Trial
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.
Read the 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.
- Conditions
- Cardiogenic Shock, Acute Kidney Injury
- Being tested
- Early initiation of continuous renal replacement therapy, Standard initiation of continuous renal replacement therapy
- Keywords
- Extracorporeal Membrane Oxygenator, Cardiogenic Shock, Acute Kidney Injury, Continuous Renal Replacement Therapy
- Medical subject headings
- Shock, Cardiogenic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early initiation of continuous renal replacement therapyDevice
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.
Standard initiation of continuous renal replacement therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated initiation of CRRT | Experimental | In the accelerated-strategy group, RRT is initiated as soon as possible and within 6 hours after patients have met full eligibility criteria. Receives: Device: Early initiation of continuous renal replacement therapy |
| Standard initiation of CRRT | Active comparator | Clinicians were discouraged from initiating RRT until the development of one or more of the following criteria.
* 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
* Oliguria (≤0.3 ml/kg/hour) or anuria for 48h or more
* Diuretics refractory fluid overload or pulmonary edema Receives: Device: Standard initiation of continuous renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality or RRT dependence
Measured: 90 days after patient enrollment
Secondary outcomes (22)
In-hospital mortality
Measured: Up to 30 days
In-hospital cardiac mortality
Measured: Up to 30 days
VA-ECMO weaning success
Measured: Up to 30 days
Time to VA-ECMO weaning
Measured: Up to 30 days
Critical limb ischemia
Measured: Up to 30 days
Access site major bleeding
Bleeding Academic Research Consortium [BARC] type 3-5
Measured: Up to 30 days
CPC 3-5
Cerebral Performance Category
Measured: Up to 30 days
Length of intensive-care unit stay
ICU Stay
Measured: Up to 30 days
Length of hospital stay
Hospital stay
Measured: Up to 30 days
Duration of mechanical ventilation
Mechanical Ventilation Maintenance
Measured: Up to 30 days
Duration of RRT
Renal Replacement Therapy
Measured: Up to 30 days
all-cause mortality
Measured: 90 days & 12 months after patient enrollment
cardiac mortality
Measured: 90 days & 12 months after patient enrollment
Requirement of cardiac replacement therapy
Left ventricular assisted device implantation or heart transplantation
Measured: 90 days & 12 months after patient enrollment
re-hospitalization due to heart failure
Measured: 90 days & 12 months after patient enrollment
re-hospitalization due to any cause
Measured: 90 days & 12 months after patient enrollment
cerebrovascular accident
ischemic or hemorrhagic
Measured: 90 days & 12 months after patient enrollment
RRT dependence
Measured: 90 days & 12 months after patient enrollment
Serum creatinine and eGFR
Measured: 90 days & 12 months after patient enrollment
major bleeding (BARC type 3, or 5)
Measured: 90 days & 12 months after patient enrollment
clinically meaningful bleeding (BARC type 2, 3, or 5)
Measured: 90 days & 12 months after patient enrollment
Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start31 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Accelerated initiation of CRRT and Standard initiation of CRRT
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696235
- Sponsor's protocol ID
- REDUCE-ECMO
- Acronym
- REDUCE-ECMO
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcceleRatEd vs. StandarD ContinUous Renal ReplaCement ThErapy for Patients With Cardiogenic Shock Undergoing Veno-arterial ExtraCorporeal Membrane Oxygenator: Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT06696235
- Acronym / sponsor ID
- REDUCE-ECMO / REDUCE-ECMO
- Conditions
- Cardiogenic Shock, Acute Kidney Injury
- Keywords
- Extracorporeal Membrane Oxygenator, Cardiogenic Shock, Acute Kidney Injury, Continuous Renal Replacement Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Accelerated initiation of CRRT and Standard initiation of CRRT
| Arm | Type | Receives |
|---|---|---|
| Accelerated initiation of CRRT | Experimental | Device: Early initiation of continuous renal replacement therapyIn the accelerated-strategy group, RRT is initiated as soon as possible and within 6 hours after patients have met full eligibility criteria. |
| Standard initiation of CRRT | Active comparator | Device: Standard initiation of continuous renal replacement therapyClinicians were discouraged from initiating RRT until the development of one or more of the following criteria. * 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 * Oliguria (≤0.3 ml/kg/hour) or anuria for 48h or more * Diuretics refractory fluid overload or pulmonary edema |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Sign of impaired organ perfusion with at least one of the following:
- altered mental status.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early initiation of continuous renal replacement therapyPatients 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 | Accelerated initiation of CRRT |
| Standard initiation of continuous renal replacement therapyPatients 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 CRRT |
Primary outcome
all-cause mortality or RRT dependence
Time frame: 90 days after patient enrollment
22 secondary outcomes
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
cardiac mortality
Time frame: 90 days & 12 months after patient enrollment
Requirement of cardiac replacement therapy
Time frame: 90 days & 12 months after patient enrollment
re-hospitalization due to heart failure
Time frame: 90 days & 12 months after patient enrollment
re-hospitalization due to any cause
Time frame: 90 days & 12 months after patient enrollment
cerebrovascular accident
Time frame: 90 days & 12 months after patient enrollment
RRT dependence
Time frame: 90 days & 12 months after patient enrollment
Serum creatinine and eGFR
Time frame: 90 days & 12 months after patient enrollment
major bleeding (BARC type 3, or 5)
Time frame: 90 days & 12 months after patient enrollment
clinically meaningful bleeding (BARC type 2, 3, or 5)
Time frame: 90 days & 12 months after patient enrollment
Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion
Time frame: Up to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early initiation of continuous renal replacement therapy and Standard initiation of continuous renal replacement therapy in people with Cardiogenic Shock and Acute Kidney Injury, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong Hoon Yang, MD, PhD (82-2-3410-3419, jhysmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality or RRT dependence (time frame: 90 days after patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.