The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Surgery Clinical Trial

Official title:

The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03007537
• Other study ID #: CSA-AKI2016
• Status: Terminated
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: December 28, 2018

Study information

• Verified date: January 2023
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Preoperative hemoglobin<130g/L;

2. Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;

3. Volunteers with informed consent.

Exclusion Criteria:

1. Patients combined with infection;

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Disease
• Heart Diseases
• Surgery
• Wounds and Injuries

Intervention

Drug:
• Erythropoietin
10000 IU erythropoietin, subcutaneous injection
• 0.9% sodium chloride
0.9% sodium chloride 1ml, subcutaneous injection

Procedure:
• cardiac surgery
included valve, coronary artery bypass graft or surgery for congenital heart diseases

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Acute Kidney Injury	Occurrence of acute kidney injury according to KDIGO guideline	7 days
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.	3 months