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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard initiation of CRRT | Active Comparator | Clinicians were discouraged from initiating RRT until the development of one or more of the following criteria.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early initiation of continuous renal replacement therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality or RRT dependence | 90 days after patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Up to 30 days | |
| In-hospital cardiac mortality | Up to 30 days | |
| VA-ECMO weaning success |
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Inclusion Criteria:
C. Sign of impaired organ perfusion with at least one of the following:
altered mental status.
cold, clammy skin and extremities.
oliguria with urine output < 30ml/h.
serum lactate > 2.0 mmol/l.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeong Hoon Yang, MD, PhD | Contact | 82-2-3410-3419 | jhysmc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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Accelerated initiation of CRRT and Standard initiation of CRRT
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Open Label Trial
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| Standard initiation of continuous renal replacement therapy | Device | 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. |
|
| Up to 30 days |
| Time to VA-ECMO weaning | Up to 30 days |
| Critical limb ischemia | Up to 30 days |
| Access site major bleeding | Bleeding Academic Research Consortium [BARC] type 3-5 | Up to 30 days |
| CPC 3-5 | Cerebral Performance Category | Up to 30 days |
| Length of intensive-care unit stay | ICU Stay | Up to 30 days |
| Length of hospital stay | Hospital stay | Up to 30 days |
| Duration of mechanical ventilation | Mechanical Ventilation Maintenance | Up to 30 days |
| Duration of RRT | Renal Replacement Therapy | Up to 30 days |
| all-cause mortality | 90 days & 12 months after patient enrollment |
| cardiac mortality | 90 days & 12 months after patient enrollment |
| Requirement of cardiac replacement therapy | Left ventricular assisted device implantation or heart transplantation | 90 days & 12 months after patient enrollment |
| re-hospitalization due to heart failure | 90 days & 12 months after patient enrollment |
| re-hospitalization due to any cause | 90 days & 12 months after patient enrollment |
| cerebrovascular accident | ischemic or hemorrhagic | 90 days & 12 months after patient enrollment |
| RRT dependence | 90 days & 12 months after patient enrollment |
| Serum creatinine and eGFR | 90 days & 12 months after patient enrollment |
| major bleeding (BARC type 3, or 5) | 90 days & 12 months after patient enrollment |
| clinically meaningful bleeding (BARC type 2, 3, or 5) | 90 days & 12 months after patient enrollment |
| Patients in the standard strategy group who received emergency RRT before 48 hours, according to criterion | Up to 48 hours |
| Samsung Medical Center | Not yet recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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