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

NCT ID: NCT02827448

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-06-30

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.

Conditions

Acute Kidney Injury; Heart Failure

Study Design

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

Eligibility Criteria

Inclusion Criteria

• Patients who will receive LVAD or heart transplantation

Exclusion Criteria

• Patients who are unable to give consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Joseph, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

Baylor Research Institute

Dallas, Texas, United States

Countries

United States

References

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Other Identifiers

BRI - 015-179

Identifier Type: -

Identifier Source: org_study_id