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Acute Kidney InjuryNCT03007537

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

A study testing Erythropoietin, 0.9% sodium chloride and cardiac surgery in people with Acute Kidney Injury and Cardiac Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Kidney Injury, Cardiac Disease, Surgery
What is being tested?
Erythropoietin, 0.9% sodium chloride and cardiac surgery
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
1 siteChina
Study dates
1 Oct 2015to 28 Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Preoperative hemoglobin<130g/L;
  • Surgery: valve, coronary artery bypass graft or surgery for congenital heart diseases;
  • Volunteers with informed consent.

Who cannot join

  • Patients combined with infection;
  • Patients with end-stage renal disease and undergoing renal replacement therapy
  • Patients with the history of thromboembolism;
  • Patients with malignant tumor and undergoing chemotherapy;
  • Patients with unmanageable hypertension (systolic pressure>200 mmHg or diastolic pressure>110mmHg);
  • Patients allergic to erythropoietin;
  • Patients injected erythropoietin within 2 weeks.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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.

Read the 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.

Being tested
Erythropoietin, 0.9% sodium chloride, cardiac surgery
Keywords
Erythropoietin, Cardiac Surgery Associated-acute Kidney Injury
Medical subject headings
Acute Kidney Injury, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythropoietinDrug

    Also called EPO

    10000 IU erythropoietin, subcutaneous injection

  • 0.9% sodium chlorideDrug

    Also called saline solution

    0.9% sodium chloride 1ml, subcutaneous injection

  • cardiac surgeryProcedure or surgery

    Also called open-heart surgery

    included valve, coronary artery bypass graft or surgery for congenital heart diseases

Study groups in NCT03007537
Study groupRoleWhat they receive
control groupPlacebo comparator0.9% sodium chloride 1ml, subcutaneous injection, once, applied 1day before cardiac surgery
Receives: Drug: 0.9% sodium chloride; Procedure: cardiac surgery
Erythropoietin groupExperimental10000 IU erythropoietin, subcutaneous injection, once, applied 1day before cardiac surgery
Receives: Drug: Erythropoietin; Procedure: cardiac surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Acute Kidney Injury

    Occurrence of acute kidney injury according to KDIGO guideline

    Measured: 7 days

Secondary outcomes (1)

  1. Number of Participants With Renal Replacement Therapy

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion28 Dec 2018
  4. Study completion28 Dec 2018

Why it stopped: lack of funds

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007537
Sponsor's protocol ID
CSA-AKI2016
Status last verified
Jan 2023
First submitted
25 Dec 2016
Last updated
26 Jan 2023
Data monitoring committee
Yes
Individual data sharing
No

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. doi: 10.1056/NEJMoa071533.

    PubMed 17804841

  • 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.

    PubMed 23033926

  • Drueke 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. doi: 10.1056/NEJMoa062276.

    PubMed 17108342

  • 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. doi: 10.1056/NEJM199808273390902.

    PubMed 9718376

  • Kim JH, Shim JK, Song JW, Song Y, Kim HB, Kwak YL. Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety. Crit Care. 2013 Oct 24;17(5):R254. doi: 10.1186/cc13081.

    PubMed 24156702

  • Oh SW, Chin HJ, Chae DW, Na KY. Erythropoietin improves long-term outcomes in patients with acute kidney injury after coronary artery bypass grafting. J Korean Med Sci. 2012 May;27(5):506-11. doi: 10.3346/jkms.2012.27.5.506. Epub 2012 Apr 25.

    PubMed 22563215

  • Togel FE, Ahlstrom JD, Yang Y, Hu Z, Zhang P, Westenfelder C. Carbamylated Erythropoietin Outperforms Erythropoietin in the Treatment of AKI-on-CKD and Other AKI Models. J Am Soc Nephrol. 2016 Nov;27(11):3394-3404. doi: 10.1681/ASN.2015091059. Epub 2016 Mar 16.

    PubMed 26984884

  • Song YR, Lee T, You SJ, Chin HJ, Chae DW, Lim C, Park KH, Han S, Kim JH, Na KY. Prevention of acute kidney injury by erythropoietin in patients undergoing coronary artery bypass grafting: a pilot study. Am J Nephrol. 2009;30(3):253-60. doi: 10.1159/000223229. Epub 2009 Jun 2.

    PubMed 19494484

  • Tasanarong A, Duangchana S, Sumransurp S, Homvises B, Satdhabudha O. Prophylaxis with erythropoietin versus placebo reduces acute kidney injury and neutrophil gelatinase-associated lipocalin in patients undergoing cardiac surgery: a randomized, double-blind controlled trial. BMC Nephrol. 2013 Jul 5;14:136. doi: 10.1186/1471-2369-14-136.

    PubMed 23829828

  • Tie HT, Luo MZ, Lin D, Zhang M, Wan JY, Wu QC. Erythropoietin administration for prevention of cardiac surgery-associated acute kidney injury: a meta-analysis of randomized controlled trials. Eur J Cardiothorac Surg. 2015 Jul;48(1):32-9. doi: 10.1093/ejcts/ezu378. Epub 2014 Oct 13.

    PubMed 25312524

Questions about this trial

What is this clinical trial studying?

A study testing Erythropoietin, 0.9% sodium chloride and cardiac surgery in people with Acute Kidney Injury and Cardiac Disease, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acute Kidney Injury (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007537, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.

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