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

Primary Purpose

Acute Kidney Injury, Cardiac Disease, Surgery

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Erythropoietin
0.9% sodium chloride
cardiac surgery
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Erythropoietin, Cardiac Surgery Associated-acute Kidney Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

Erythropoietin group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Acute Kidney Injury
Occurrence of acute kidney injury according to KDIGO guideline

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2016
Last Updated
January 8, 2023
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03007537
Brief Title
The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury
Official Title
The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
lack of funds
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Cardiac Disease, Surgery
Keywords
Erythropoietin, Cardiac Surgery Associated-acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
Arm Title
Erythropoietin group
Arm Type
Experimental
Arm Description
10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
EPO
Intervention Description
10000 IU erythropoietin, subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
saline solution
Intervention Description
0.9% sodium chloride 1ml, subcutaneous injection
Intervention Type
Procedure
Intervention Name(s)
cardiac surgery
Other Intervention Name(s)
open-heart surgery
Intervention Description
included valve, coronary artery bypass graft or surgery for congenital heart diseases
Primary Outcome Measure Information:
Title
Number of Participants With Acute Kidney Injury
Description
Occurrence of acute kidney injury according to KDIGO guideline
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of Participants With Renal Replacement Therapy
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preoperative hemoglobin<130g/L; Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases; Volunteers with informed consent. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xin Wan, Doctor
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Changchun Cao, Doctor
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xin Du, Doctor
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17804841
Citation
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Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
17108342
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.
Results Reference
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PubMed Identifier
9718376
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
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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.
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PubMed Identifier
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Citation
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Citation
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The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury

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