Clinical trial NCT02827448: Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
Official title: Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Heart Failure
Keywords: Left Ventricular Assist Device
Heart Transplantation
Perioperative
Acute Kidney Injury
Renal
Kidney
Total Artificial Heart
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have had a heart transplant or LVAD implant.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who will receive LVAD or heart transplantation

Exclusion Criteria:

* Patients who are unable to give consent

Primary outcomes:
measure: [TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation
timeFrame: 1 year
measure: Occurrence of AKI following LVAD or TAH implantation
timeFrame: 1 year
Secondary outcomes:
measure: [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor University
name: Susan Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
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