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The purpose of this study is to determine whether erythropoietin is effective in preventing acute kidney dysfunction after coronary artery bypass grafting surgery.
Acute kidney injury (AKI) occurs in 7% to 40% of patients undergoing cardiac surgery, depending on the definition of AKI used. Even small increments in serum creatinine have been shown to be associated with increased mortality after cardiac surgery. However, there are no proven interventions to prevent AKI after cardiac surgery. Erythropoietin (EPO) has been shown to have tissue-protective effects in various experimental models. In this prospective placebo-controlled randomized trial, we evaluated the effectiveness of EPO in the prevention of AKI after coronary artery bypass grafting (CABG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO group | Active Comparator |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin-Beta | Drug | 300 IU/kg of EPO or saline intravenously before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had AKI (Acute Kidney Injury) | number of participants who had 50% increase in serum creatinine levels from baseline | at any time within the first 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (eGFR) | estimated glomerular filtration rate (eGFR)as ml/min/1.73m2 | during the first 5 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Young, Na, MD PhD | Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39301879 | Derived | Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythropoietin (EPO) Group | received 300 U/kg of erythropoietin intraveously following induction of anesthesia |
| FG001 | Placebo Group | received normal saline intraveously following induction of anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythropoietin (EPO) Group | received 300 U/kg of erythropoietin intraveously following induction of anesthesia |
| BG001 | Placebo Group | received normal saline intraveously following induction of anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change in Estimated Glomerular Filtration Rate (eGFR) | estimated glomerular filtration rate (eGFR)as ml/min/1.73m2 | Posted | Mean | Standard Deviation | ml/min/1.73m2 | during the first 5 days after surgery |
|
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Effect of erythropoietin in kidney after cardiac surgery | Seoul National University Bundang Hospital | 82-31-787-7014 | kyna@snubh.org |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline | Drug | 300 IU/kg of normal saline intravenously before surgery |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Participants Who Had AKI (Acute Kidney Injury) | number of participants who had 50% increase in serum creatinine levels from baseline | Posted | Number | participants | at any time within the first 5 days after surgery |
|
|
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |