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

Nanjing Medical University

Status: Terminated

Conditions: Cardiac Disease; Surgery; Acute Kidney Injury

Treatments: Drug: 0.9% sodium chloride; Drug: Erythropoietin; Procedure: cardiac surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03007537

CSA-AKI2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

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

Treatment:

Procedure: cardiac surgery

Drug: 0.9% sodium chloride

Erythropoietin group

Experimental group

Description:

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

Treatment:

Procedure: cardiac surgery

Drug: Erythropoietin