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

NCT03007537 | Terminated Results DMC

• 1 other identifier: CSA-AKI2016
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Cardiac Disease; Surgery

Keywords

Erythropoietin; Cardiac Surgery Associated-acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acute Kidney Injury

  Occurrence of acute kidney injury according to KDIGO guideline

  7 days

Secondary Outcomes (1)

• Number of Participants With Renal Replacement Therapy

  3 months

Study Arms (2)

control group

PLACEBO COMPARATOR

0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery

Drug: 0.9% sodium chloride; Procedure: cardiac surgery

Erythropoietin group

EXPERIMENTAL

10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery

Drug: Erythropoietin; Procedure: cardiac surgery

Interventions

Erythropoietin DRUG

10000 IU erythropoietin, subcutaneous injection

Also known as: EPO

Erythropoietin group

0.9% sodium chloride DRUG

0.9% sodium chloride 1ml, subcutaneous injection

Also known as: saline solution

control group

cardiac surgery PROCEDURE

included valve, coronary artery bypass graft or surgery for congenital heart diseases

Also known as: open-heart surgery

Erythropoietin group; control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative hemoglobin\<130g/L;
• Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;
• Volunteers with informed consent.

You may not qualify if:

• Patients combined with infection;
• Patients with end-stage renal disease and undergoing renal replacement therapy
• Patients with the history of thromboembolism;
• Patients with malignant tumor and undergoing chemotherapy;
• Patients with unmanageable hypertension (systolic pressure\>200 mmHg or diastolic pressure\>110mmHg);
• Patients allergic to erythropoietin;
• Patients injected erythropoietin within 2 weeks.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Location

Related 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.

  PMID: 17804841 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.

  PMID: 23033926 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.

  PMID: 17108342 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.

  PMID: 9718376 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.

  PMID: 24156702 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.

  PMID: 22563215 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.

  PMID: 26984884 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.

  PMID: 19494484 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.

  PMID: 23829828 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.

  PMID: 25312524 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Heart Diseases

Interventions

Erythropoietin; Sodium Chloride; Saline Solution; Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Results Point of Contact

• Title: Dr. Xiaobin Ji
• Organization: Nanjing First Hospital, Nanjing Medical University

xbji007@126.com

13705174622

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2015
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)