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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL085757 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum creatinine levels (absolute and percentage) | Measured in the 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Doubling of serum creatinine, use of dialysis, or death | Measured during hospitalization |
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Inclusion Criteria for Adults: (must have at least one of the following)
Exclusion Criteria for Adults:
Inclusion Criteria for Children:
Exclusion Criteria for Children:
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| Name | Affiliation | Role |
|---|---|---|
| Chirag R. Parikh, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States | ||
| Danbury Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21836143 | Result | 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. | |
| 21336114 | Result | 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. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Urine, plasma, buffy coat (optional)
| Danbury |
| Connecticut |
| 06810 |
| United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| University of Chicago School of Medicine | Chicago | Illinois | 60637 | United States |
| Duke Clinical Research Institute | Durham | North Carolina | 27705 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| Montreal Children's Hospital at McGill University Health Centre | Montreal | Quebec | H3H 1P3 | Canada |
| 21836147 | Result | 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. |
| 21601336 | Result | 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. |
| 21525851 | Result | 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. |
| 37947177 | Derived | 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. |
| 33974569 | Derived | 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. |
| 24996668 | Derived | 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. |
| 24725832 | Derived | 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. |
| 22383693 | Derived | 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. |
| 22322531 | Derived | 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. |
| 22050987 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |