NCT00774137

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

5.8 years

First QC Date

October 16, 2008

Last Update Submit

April 1, 2020

Conditions

Kidney Failure, AcuteRenal Insufficiency

Keywords

Acute Kidney InjuryIL-18NGALCystatin CBiomarkersDialysis

Outcome Measures

Primary Outcomes (1)

  • Changes in serum creatinine levels (absolute and percentage)

    Measured in the 1 week after surgery

Secondary Outcomes (1)

  • Doubling of serum creatinine, use of dialysis, or death

    Measured during hospitalization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Emergent surgery
  • Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL)
  • Ejection fraction less than 35%
  • At least 70 years old
  • Diabetes mellitus
  • Combined CABG and valve surgery
  • Repeat CABG or valve surgery

You may not qualify if:

  • 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
  • Undergoing open heart surgery
  • Pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

University of Chicago School of Medicine

Chicago, Illinois, 60637, United States

Location

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Montreal Children's Hospital at McGill University Health Centre

Montreal, Quebec, H3H 1P3, Canada

Location

Related Publications (12)

  • 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.

    PMID: 21836143RESULT

  • 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.

    PMID: 21336114RESULT

  • 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.

    PMID: 21836147RESULT

  • 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.

    PMID: 21601336RESULT

  • 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.

    PMID: 21525851RESULT

  • 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.

    PMID: 37947177DERIVED

  • 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.

    PMID: 33974569DERIVED

  • 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.

    PMID: 24996668DERIVED

  • 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.

    PMID: 24725832DERIVED

  • 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.

    PMID: 22383693DERIVED

  • 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.

    PMID: 22322531DERIVED

  • 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.

    PMID: 22050987DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, plasma, buffy coat (optional)

MeSH Terms

Conditions

Acute Kidney InjuryRenal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chirag R. Parikh, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

April 1, 2007

Primary Completion

February 1, 2013

Study Completion

February 1, 2014

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations

US(6)CA(2)