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Kidney Failure, AcuteNCT00774137

Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

An observational study of Kidney Failure, Acute and Renal Insufficiency, run by Yale University at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may experience acute kidney injury (AKI) after their surgery. Current medical tests cannot identify AKI until approximately 48 hours after it occurs. Read more about this study

Who is it for?
Any age
Conditions the study is for
Kidney Failure, Acute, Renal Insufficiency
How many people
1,550 participants
Where
8 sitesin 2 countries
Study dates
Apr 2007to Feb 2014
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 1. Adults undergoing CABG surgery or heart valve surgery. 2. Children undergoing cardic surgery (requiring CABG) to correct congenital heart defects.

Who may be able to join

  • Undergoing open heart surgery

Who cannot join

  • Pre-operative acute kidney injury
  • Enrolled in a conflicting research study
  • Prior kidney transplantation
  • Baseline serum creatinine level greater than 4.5 mg/dL
  • Nephrotoxic drugs administered pre-operatively
  • Surgery for only left ventricular assist device
  • Pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States6 sites

  • University of Chicago School of Medicine

    Chicago, Illinois, 60637

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Duke Clinical Research Institute

    Durham, North Carolina, 27705

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

Other trials in United States

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Montreal Children's Hospital at McGill University Health Centre

    Montreal, Quebec, H3H 1P3

Other trials in Canada

About this study

Official title: Phase IV Multi Center Validation Study of Novel Biomarkers of Acute Kidney Injury After Cardiac Surgery

People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may experience acute kidney injury (AKI) after their surgery. Current medical tests cannot identify AKI until approximately 48 hours after it occurs. This study will examine three new biomarkers in blood and urine that may provide a more effective and faster way of predicting AKI in people who undergo CABG or heart valve surgery.

Read the detailed description

AKI, which is indicated by a sudden change in serum creatinine levels, is a serious complication that can occur after a patient undergoes CABG or heart valve surgery. People who experience AKI after heart surgery may be at increased risk for post-operative complications, including long-term kidney failure or heart damage. AKI is currently identified by testing serum creatinine levels in the blood, which is the traditional marker of kidney function. However, serum creatinine levels can be affected by other non-kidney-related factors and may not positively identify AKI until 48 hours after it begins. This study will examine three new biomarkers found in urine and blood-urine interleukin 18 (IL-18), neutrophil gelatinase-associated lipocalin (NGAL), and cystatin C-that may be able to predict AKI more effectively and faster than serum creatinine levels. In addition, study researchers will also determine if changes in these biomarkers can predict the severity of AKI more successfully than serum creatinine tests.

This study will enroll people undergoing CABG or heart valve surgery at Yale-New Haven Hospital. Before the surgery and once a day for 5 days after the surgery, blood and urine collection will occur. Study researchers will also review participants' medical records. Twelve months after hospital discharge, participants will return to the clinic for a follow-up visit for repeat blood and urine collection and to complete questionnaires. A portion of blood will be saved for future genetic testing; this is optional.

Keywords
Acute Kidney Injury, IL-18, NGAL, Cystatin C, Biomarkers, Dialysis
Medical subject headings
Acute Kidney Injury, Renal Insufficiency

What is being measured

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

  1. Changes in serum creatinine levels (absolute and percentage)

    Measured: Measured in the 1 week after surgery

Secondary outcomes (1)

  1. Doubling of serum creatinine, use of dialysis, or death

    Measured: Measured during hospitalization

Timeline

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

  1. First posted17 Oct 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionFeb 2013
  4. Study completionFeb 2014

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774137
Sponsor's protocol ID
0603001221
Other IDs
R01HL085757
Status last verified
Apr 2020
First submitted
16 Oct 2008
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Parikh CR, Coca SG, Thiessen-Philbrook H, Shlipak MG, Koyner JL, Wang Z, Edelstein CL, Devarajan P, Patel UD, Zappitelli M, Krawczeski CD, Passik CS, Swaminathan M, Garg AX; TRIBE-AKI Consortium. Postoperative biomarkers predict acute kidney injury and poor outcomes after adult cardiac surgery. J Am Soc Nephrol. 2011 Sep;22(9):1748-57. doi: 10.1681/ASN.2010121302. Epub 2011 Aug 11.

    PubMed 21836143

  • Li S, Krawczeski CD, Zappitelli M, Devarajan P, Thiessen-Philbrook H, Coca SG, Kim RW, Parikh CR; TRIBE-AKI Consortium. Incidence, risk factors, and outcomes of acute kidney injury after pediatric cardiac surgery: a prospective multicenter study. Crit Care Med. 2011 Jun;39(6):1493-9. doi: 10.1097/CCM.0b013e31821201d3.

    PubMed 21336114

  • Parikh CR, Devarajan P, Zappitelli M, Sint K, Thiessen-Philbrook H, Li S, Kim RW, Koyner JL, Coca SG, Edelstein CL, Shlipak MG, Garg AX, Krawczeski CD; TRIBE-AKI Consortium. Postoperative biomarkers predict acute kidney injury and poor outcomes after pediatric cardiac surgery. J Am Soc Nephrol. 2011 Sep;22(9):1737-47. doi: 10.1681/ASN.2010111163. Epub 2011 Aug 11.

    PubMed 21836147

  • Shlipak MG, Coca SG, Wang Z, Devarajan P, Koyner JL, Patel UD, Thiessen-Philbrook H, Garg AX, Parikh CR; TRIBE-AKI Consortium. Presurgical serum cystatin C and risk of acute kidney injury after cardiac surgery. Am J Kidney Dis. 2011 Sep;58(3):366-73. doi: 10.1053/j.ajkd.2011.03.015. Epub 2011 May 20.

    PubMed 21601336

  • Zappitelli M, Krawczeski CD, Devarajan P, Wang Z, Sint K, Thiessen-Philbrook H, Li S, Bennett MR, Ma Q, Shlipak MG, Garg AX, Parikh CR; TRIBE-AKI consortium. Early postoperative serum cystatin C predicts severe acute kidney injury following pediatric cardiac surgery. Kidney Int. 2011 Sep;80(6):655-62. doi: 10.1038/ki.2011.123. Epub 2011 Apr 27.

    PubMed 21525851

  • Kavsak PA, Belley-Cote EP, Whitlock RP, Lamy A. Cardiac troponin testing in cardiac surgery. Expert Rev Cardiovasc Ther. 2023 Jul-Dec;21(11):729-731. doi: 10.1080/14779072.2023.2283123. Epub 2023 Dec 10. No abstract available.

    PubMed 37947177

  • Menez S, Ju W, Menon R, Moledina DG, Thiessen Philbrook H, McArthur E, Jia Y, Obeid W, Mansour SG, Koyner JL, Shlipak MG, Coca SG, Garg AX, Bomback AS, Kellum JA, Kretzler M, Parikh CR; Translational Research Investigating Biomarker Endpoints in AKI (TRIBE-AKI) Consortium and the Kidney Precision Medicine Project. Urinary EGF and MCP-1 and risk of CKD after cardiac surgery. JCI Insight. 2021 Jun 8;6(11):e147464. doi: 10.1172/jci.insight.147464.

    PubMed 33974569

  • Koyner JL, Garg AX, Thiessen-Philbrook H, Coca SG, Cantley LG, Peixoto A, Passik CS, Hong K, Parikh CR; TRIBE-AKI Consortium. Adjudication of etiology of acute kidney injury: experience from the TRIBE-AKI multi-center study. BMC Nephrol. 2014 Jul 4;15:105. doi: 10.1186/1471-2369-15-105.

    PubMed 24996668

  • Hornik CP, Krawczeski CD, Zappitelli M, Hong K, Thiessen-Philbrook H, Devarajan P, Parikh CR, Patel UD; TRIBE-AKI Consortium. Serum brain natriuretic peptide and risk of acute kidney injury after cardiac operations in children. Ann Thorac Surg. 2014 Jun;97(6):2142-7. doi: 10.1016/j.athoracsur.2014.02.035. Epub 2014 Apr 13.

    PubMed 24725832

  • Koyner JL, Garg AX, Coca SG, Sint K, Thiessen-Philbrook H, Patel UD, Shlipak MG, Parikh CR; TRIBE-AKI Consortium. Biomarkers predict progression of acute kidney injury after cardiac surgery. J Am Soc Nephrol. 2012 May;23(5):905-14. doi: 10.1681/ASN.2011090907. Epub 2012 Mar 1.

    PubMed 22383693

  • Patel UD, Garg AX, Krumholz HM, Shlipak MG, Coca SG, Sint K, Thiessen-Philbrook H, Koyner JL, Swaminathan M, Passik CS, Parikh CR; Translational Research Investigating Biomarker Endpoints in Acute Kidney Injury (TRIBE-AKI) Consortium. Preoperative serum brain natriuretic peptide and risk of acute kidney injury after cardiac surgery. Circulation. 2012 Mar 20;125(11):1347-55. doi: 10.1161/CIRCULATIONAHA.111.029686. Epub 2012 Feb 9.

    PubMed 22322531

  • Coca SG, Jammalamadaka D, Sint K, Thiessen Philbrook H, Shlipak MG, Zappitelli M, Devarajan P, Hashim S, Garg AX, Parikh CR; Translational Research Investigating Biomarker Endpoints in Acute Kidney Injury Consortium. Preoperative proteinuria predicts acute kidney injury in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2012 Feb;143(2):495-502. doi: 10.1016/j.jtcvs.2011.09.023. Epub 2011 Nov 3.

    PubMed 22050987

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Failure, Acute and Renal Insufficiency, run by Yale University at 8 sites in 2 countries.

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 1 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: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in serum creatinine levels (absolute and percentage) (time frame: Measured in the 1 week after surgery). 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 NCT00774137, which also lists 12 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 3 Apr 2020.

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