Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

NCT02827448 | Completed

• 1 other identifier: BRI - 015-179
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

Conditions

Acute Kidney Injury; Heart Failure

Keywords

Left Ventricular Assist Device; Heart Transplantation; Perioperative; Acute Kidney Injury; Renal; Kidney; Total Artificial Heart

Outcome Measures

Primary Outcomes (2)

• [TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation

  1 year

• Occurrence of AKI following LVAD or TAH implantation

  1 year

Secondary Outcomes (1)

• [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation

  1 year

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have had a heart transplant or LVAD implant.

You may qualify if:

• Patients who will receive LVAD or heart transplantation

You may not qualify if:

• Patients who are unable to give consent

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75204, United States

Location

Related Publications (8)

• Hobson CE, Yavas S, Segal MS, Schold JD, Tribble CG, Layon AJ, Bihorac A. Acute kidney injury is associated with increased long-term mortality after cardiothoracic surgery. Circulation. 2009 May 12;119(18):2444-53. doi: 10.1161/CIRCULATIONAHA.108.800011. Epub 2009 Apr 27.

  PMID: 19398670 BACKGROUND

• Boyle JM, Moualla S, Arrigain S, Worley S, Bakri MH, Starling RC, Heyka R, Thakar CV. Risks and outcomes of acute kidney injury requiring dialysis after cardiac transplantation. Am J Kidney Dis. 2006 Nov;48(5):787-96. doi: 10.1053/j.ajkd.2006.08.002.

  PMID: 17059998 BACKGROUND

• Odim J, Wheat J, Laks H, Kobashigawa J, Gjertson D, Osugi A, Mukherjee K, Saleh S. Peri-operative renal function and outcome after orthotopic heart transplantation. J Heart Lung Transplant. 2006 Feb;25(2):162-6. doi: 10.1016/j.healun.2005.07.011.

  PMID: 16446215 BACKGROUND

• Topkara VK, Dang NC, Barili F, Cheema FH, Martens TP, George I, Bardakci H, Oz MC, Naka Y. Predictors and outcomes of continuous veno-venous hemodialysis use after implantation of a left ventricular assist device. J Heart Lung Transplant. 2006 Apr;25(4):404-8. doi: 10.1016/j.healun.2005.11.457. Epub 2006 Feb 28.

  PMID: 16563969 BACKGROUND

• Borgi J, Tsiouris A, Hodari A, Cogan CM, Paone G, Morgan JA. Significance of postoperative acute renal failure after continuous-flow left ventricular assist device implantation. Ann Thorac Surg. 2013 Jan;95(1):163-9. doi: 10.1016/j.athoracsur.2012.08.076. Epub 2012 Oct 25.

  PMID: 23103012 BACKGROUND

• Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.

  PMID: 23388612 BACKGROUND

• Bihorac A, Chawla LS, Shaw AD, Al-Khafaji A, Davison DL, Demuth GE, Fitzgerald R, Gong MN, Graham DD, Gunnerson K, Heung M, Jortani S, Kleerup E, Koyner JL, Krell K, Letourneau J, Lissauer M, Miner J, Nguyen HB, Ortega LM, Self WH, Sellman R, Shi J, Straseski J, Szalados JE, Wilber ST, Walker MG, Wilson J, Wunderink R, Zimmerman J, Kellum JA. Validation of cell-cycle arrest biomarkers for acute kidney injury using clinical adjudication. Am J Respir Crit Care Med. 2014 Apr 15;189(8):932-9. doi: 10.1164/rccm.201401-0077OC.

  PMID: 24559465 BACKGROUND

• Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.

  PMID: 24675717 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Heart Failure

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Susan Joseph, MD

  Baylor 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: November 24, 2015
• First Posted: July 11, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

US (1)