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

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03007537
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Actual Duration (Months): 38.9
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Cardiac Disease; Surgery	Drug: Erythropoietin; Drug: 0.9% sodium chloride; Procedure: cardiac surgery	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 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
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 28, 2018
• Actual Study Completion Date: Dec 28, 2018

Arms and Interventions

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 Names: saline solution ; Procedure: cardiac surgery; included valve, coronary artery bypass graft or surgery for congenital heart diseases; Other Names: 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 Names: EPO ; Procedure: cardiac surgery; included valve, coronary artery bypass graft or surgery for congenital heart diseases; Other Names: open-heart surgery

Outcome Measures

Primary Outcome Measures

1. Occurrence of acute kidney injury [7 days]

   According to KDIGO2012

Secondary Outcome Measures

1. Death [3 months]

2. Need for renal replacement therapy [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Drüeke 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.
• 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.

• Responsible Party: Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT03007537
• Other Study ID Numbers: CSA-AKI2016
• First Posted: Jan 2, 2017
• Last Update Posted: Mar 18, 2020
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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: Acute Kidney Injury; Heart Diseases; Wounds and Injuries; Epoetin Alfa

Study Results

No Results Posted as of Mar 18, 2020