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

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ClinicalTrials.gov Identifier: NCT03007537
Recruitment Status : Unknown
Verified December 2016 by Nanjing First Hospital, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Cardiac Disease Surgery Drug: Erythropoietin Drug: 0.9% sodium chloride Procedure: cardiac surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Prevention of Erythropoietin on Cardiac Surgery-associated Acute Kidney Injury
Study Start Date : October 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Placebo Comparator: control group
0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
Drug: 0.9% sodium chloride
0.9% sodium chloride 1ml, subcutaneous injection
Other Name: saline solution

Procedure: cardiac surgery
included valve, coronary artery bypass graft or surgery for congenital heart diseases
Other Name: open-heart surgery

Experimental: Erythropoietin group
10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
Drug: Erythropoietin
10000 IU erythropoietin, subcutaneous injection
Other Name: EPO

Procedure: cardiac surgery
included valve, coronary artery bypass graft or surgery for congenital heart diseases
Other Name: open-heart surgery




Primary Outcome Measures :
  1. Occurrence of acute kidney injury [ Time Frame: 7 days ]
    According to KDIGO2012


Secondary Outcome Measures :
  1. Death [ Time Frame: 3 months ]
  2. Need for renal replacement therapy [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007537


Contacts
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Contact: Xiaobin Ji, Doctor 13705174622 xbji007@126.com
Contact: Jing Li, Master 18360868329 azalea0557@hotmail.com

Locations
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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Xin Wan, Doctor    18951670991    wanxin73@163.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Chair: Xin Chen, Doctor Nanjing First Hospital, Nanjing Medical University
Study Director: Xin Wan, Doctor Nanjing First Hospital, Nanjing Medical University
Study Director: Changchun Cao, Doctor Nanjing First Hospital, Nanjing Medical University
Principal Investigator: Xin Du, Doctor Nanjing First Hospital, Nanjing Medical University

Publications of Results:

Other Publications:
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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03007537     History of Changes
Other Study ID Numbers: CSA-AKI2016
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
Erythropoietin
Cardiac Surgery Associated-acute Kidney Injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Heart Diseases
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Diseases
Epoetin Alfa
Hematinics