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To testify the prevention of Erythropoietin on cardiac surgery associated-acute kidney injury, and trying to provide evidence for protecting the renal function and improving the prognosis for patients after cardiac surgery.
Patients meet the inclusion criteria and agree to sign an informed consent will be randomly assigned into the control group or erythropoietin group.Interventions will be applied 1 day(24hrs) before the cardiac surgery. Blood and Urine samples will be collected after the surgery. By using the criterion given by KDIGO2012 and testing the biomarkers for acute kidney injury, we hope to find out if there is an association between erythropoietin administration and the occurence of acute kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery |
|
| Erythropoietin group | Experimental | 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin | Drug | 10000 IU erythropoietin, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Kidney Injury | Occurrence of acute kidney injury according to KDIGO guideline | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Renal Replacement Therapy | suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Chen, Doctor | Nanjing First Hospital, Nanjing Medical University | Study Chair |
| Xin Wan, Doctor | Nanjing First Hospital, Nanjing Medical University | Study Director |
| Changchun Cao, Doctor | Nanjing First Hospital, Nanjing Medical University | Study Director |
| Xin Du, Doctor | Nanjing First Hospital, Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17804841 | Background | Corwin HL, Gettinger A, Fabian TC, May A, Pearl RG, Heard S, An R, Bowers PJ, Burton P, Klausner MA, Corwin MJ; EPO Critical Care Trials Group. Efficacy and safety of epoetin alfa in critically ill patients. N Engl J Med. 2007 Sep 6;357(10):965-76. doi: 10.1056/NEJMoa071533. | |
| 23033926 | Background | de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases |
| FG001 | Erythropoietin Group | 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases |
| BG001 |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acute Kidney Injury | Occurrence of acute kidney injury according to KDIGO guideline | Posted | Number | participants | 7 days |
|
3 months
pulmonary infection, thrombotic events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | 0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery 0.9% sodium chloride: 0.9% sodium chloride 1ml, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombotic events | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaobin Ji | Nanjing First Hospital, Nanjing Medical University | 13705174622 | xbji007@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2020 | Jan 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| 0.9% sodium chloride | Drug | 0.9% sodium chloride 1ml, subcutaneous injection |
|
|
| cardiac surgery | Procedure | included valve, coronary artery bypass graft or surgery for congenital heart diseases |
|
|
| 17108342 | Background | Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276. |
| 9718376 | Background | Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA. Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients. N Engl J Med. 1998 Aug 27;339(9):578-83. doi: 10.1056/NEJM199808273390902. |
| 24156702 | Background | Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081. |
| 22563215 | Background | Oh SW, Chin HJ, Chae DW, Na KY. Erythropoietin improves long-term outcomes in patients with acute kidney injury after coronary artery bypass grafting. J Korean Med Sci. 2012 May;27(5):506-11. doi: 10.3346/jkms.2012.27.5.506. Epub 2012 Apr 25. |
| 26984884 | Background | Togel FE, Ahlstrom JD, Yang Y, Hu Z, Zhang P, Westenfelder C. Carbamylated Erythropoietin Outperforms Erythropoietin in the Treatment of AKI-on-CKD and Other AKI Models. J Am Soc Nephrol. 2016 Nov;27(11):3394-3404. doi: 10.1681/ASN.2015091059. Epub 2016 Mar 16. |
| 19494484 | Background | Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2. |
| 23829828 | Background | Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136. |
| 25312524 | Background | Tie HT, Luo MZ, Lin D, Zhang M, Wan JY, Wu QC. Erythropoietin administration for prevention of cardiac surgery-associated acute kidney injury: a meta-analysis of randomized controlled trials. Eur J Cardiothorac Surg. 2015 Jul;48(1):32-9. doi: 10.1093/ejcts/ezu378. Epub 2014 Oct 13. |
| Erythropoietin Group |
10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| serum creatinine | Mean | Standard Deviation | μmo/L |
|
|
|
| Secondary | Number of Participants With Renal Replacement Therapy | suffering from severe acute kidney injury(3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l)), olignuria≥24 hours or anuria≥12 hours. | Posted | Number | participants | 3 months |
|
|
|
| 0 |
| 46 |
| 10 |
| 46 |
| 0 |
| 46 |
| EG001 | Erythropoietin Group | 10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery Erythropoietin: 10000 IU erythropoietin, subcutaneous injection cardiac surgery: included valve, coronary artery bypass graft or surgery for congenital heart diseases | 0 | 46 | 9 | 46 | 0 | 46 |
| pulmonary infection | Infections and infestations | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002318 | Cardiovascular Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |