The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury
NCT ID: NCT03007537
Last Updated: 2023-01-26
Study Results
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View full resultsBasic Information
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TERMINATED
NA
101 participants
INTERVENTIONAL
2015-10-01
2018-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
Interventions
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Erythropoietin
10000 IU erythropoietin, subcutaneous injection
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;
3. Volunteers with informed consent.
Exclusion Criteria
2. Patients with end-stage renal disease and undergoing renal replacement therapy
3. Patients with the history of thromboembolism;
4. Patients with malignant tumor and undergoing chemotherapy;
5. Patients with unmanageable hypertension (systolic pressure\>200 mmHg or diastolic pressure\>110mmHg);
6. Patients allergic to erythropoietin;
7. Patients injected erythropoietin within 2 weeks.
18 Years
80 Years
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Principal Investigators
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Xin Chen, Doctor
Role: STUDY_CHAIR
Nanjing First Hospital, Nanjing Medical University
Xin Wan, Doctor
Role: STUDY_DIRECTOR
Nanjing First Hospital, Nanjing Medical University
Changchun Cao, Doctor
Role: STUDY_DIRECTOR
Nanjing First Hospital, Nanjing Medical University
Xin Du, Doctor
Role: PRINCIPAL_INVESTIGATOR
Nanjing First Hospital, Nanjing Medical University
Locations
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Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CSA-AKI2016
Identifier Type: -
Identifier Source: org_study_id
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