Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/9/2017 |
| Start Date: | November 2015 |
| End Date: | November 2018 |
| Contact: | Horacio Martinez, BS, CCRC |
| Email: | Horacio.Martinez@BSWHealth.org |
| Phone: | 214-820-0338 |
Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
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.
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.
Current strategies for AKI detection rely primarily on elevations in serum creatinine in
conjunction with diminished urine output. Unfortunately, deviations in these crude parameters
of renal function are largely insensitive and late manifestations of AKI, where acute tubular
necrosis has likely already transpired and therefore well beyond the phase where preventive
measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding
protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical
mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular
injury, providing a potential therapeutic window to prevent permanent damage. To date, no
study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in
advanced heart failure patients undergoing cardiac replacement therapies.
Therefore, the aim of this prospective observational study will be to evaluate the
effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD
implant, or TAH implant.
conjunction with diminished urine output. Unfortunately, deviations in these crude parameters
of renal function are largely insensitive and late manifestations of AKI, where acute tubular
necrosis has likely already transpired and therefore well beyond the phase where preventive
measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding
protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical
mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular
injury, providing a potential therapeutic window to prevent permanent damage. To date, no
study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in
advanced heart failure patients undergoing cardiac replacement therapies.
Therefore, the aim of this prospective observational study will be to evaluate the
effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD
implant, or TAH implant.
Inclusion Criteria:
- Patients who will receive LVAD or heart transplantation
Exclusion Criteria:
- Patients who are unable to give consent
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