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

January 8, 2023 updated by: Nanjing First Hospital, Nanjing Medical University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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
Procedure: cardiac surgery
included valve, coronary artery bypass graft or surgery for congenital heart diseases
Other Names:
  • open-heart surgery
Drug: Erythropoietin
10000 IU erythropoietin, subcutaneous injection
Other Names:
  • EPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Acute Kidney Injury
Time Frame: 7 days
Occurrence of acute kidney injury according to KDIGO guideline
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 28, 2018

Study Completion (Actual)

December 28, 2018

Study Registration Dates

First Submitted

December 25, 2016

First Submitted That Met QC Criteria

December 29, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA-AKI2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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