Clinical trial NCT03007537: 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
Overall status: TERMINATED
Phase: NA
Conditions: Acute Kidney Injury
Cardiac Disease
Surgery
Keywords: Erythropoietin
Cardiac Surgery Associated-acute Kidney Injury
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Acute Kidney Injury
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants With Renal Replacement Therapy
timeFrame: 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Xin Chen, Doctor
role: STUDY_CHAIR
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Xin Wan, Doctor
role: STUDY_DIRECTOR
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Changchun Cao, Doctor
role: STUDY_DIRECTOR
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Xin Du, Doctor
role: PRINCIPAL_INVESTIGATOR
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