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

Not Applicable

Terminated

• Conditions: Surgery; Acute Kidney Injury; Cardiac Disease
• Interventions: Drug: 0.9% sodium chloride; Drug: Erythropoietin; Procedure: cardiac surgery

• Registration Number: NCT03007537
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-12-25
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2017-01-02
• Primary Completion: 2018-12-28
• Study Completion: 2018-12-28
• Results First Submitted: 2021-03-02
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-08
• Last Update Submitted: 2023-01-08
• Results First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	cardiac surgery	0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
Erythropoietin group	cardiac surgery	10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
control group	0.9% sodium chloride	0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
Erythropoietin group	Erythropoietin	10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With Acute Kidney Injury	7 days	Occurrence of acute kidney injury according to KDIGO guideline

Secondary Outcome Measures

Name	Time	Method
Number of Participants With 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.

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China