Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

NCT ID: NCT00774137

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2014-02-28

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.

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.

Conditions

Kidney Failure, Acute; Renal Insufficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

• Undergoing open heart surgery

Exclusion Criteria

• 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chirag R. Parikh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of Colorado Health Sciences Center

Denver, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Yale University School of Medicine

New Haven, Connecticut, United States

University of Chicago School of Medicine

Chicago, Illinois, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

London Health Sciences Centre

London, Ontario, Canada

Montreal Children's Hospital at McGill University Health Centre

Montreal, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 21836143 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21336114 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21836147 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21601336 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21525851 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37947177 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33974569 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24996668 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24725832 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22383693 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22322531 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22050987 (View on PubMed)

Other Identifiers

R01HL085757

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0603001221

Identifier Type: -

Identifier Source: org_study_id