Abstract
BackgroundAcute kidney injury (AKI), which is common among HIV-positive individuals, may contribute to the excess burden of chronic kidney disease (CKD) in this patient population; however, conventional clinical methods to detect AKI do not capture kidney injury sufficiently early to prevent irreversible damage. Further, large observational and interventional studies of AKI generally exclude HIV-positive persons in spite of their disproportionate risk.MethodsThe Predictors of Acute Renal Injury Study (PARIS) is a prospective observational cohort study among HIV-positive individuals established to determine the ability of candidate kidney injury biomarkers to predict future hospitalized clinical AKI, to characterize hospitalized subclinical AKI, and to discern the risk of progressive kidney disease following subclinical and clinical AKI. Among the candidate kidney injury markers, we will select the most promising to translate into a clinically viable, multiplex panel of urinary biomarkers which we will integrate with clinical factors to develop a model prognostic of risks for AKI and subsequent kidney function decline. This study has a targeted enrollment of 2000 participants. The overall follow-up of participants consists of two phases: 1) a 5-year active follow-up phase which involves serial evaluations at enrollment, annual clinic visits, and among participants who are hospitalized during this period, an evaluation at index hospitalization and 3 and 12 months post-hospitalization; and 2) a subsequent passive follow-up phase for the duration that the participant receives medical care at The Johns Hopkins Hospital.DiscussionsThis study will serve as an important resource for future studies of AKI by establishing a repository with both ambulatory and inpatient biospecimens, a resource that is currently lacking in existing HIV clinical cohorts and studies of AKI. Upon completion of this study, the resulting prognostic model which will incorporate results from the multiplex HIV-AKI Risk Pane could serve as a pharmacodynamic endpoint for early phase therapeutic candidates for AKI.
Highlights
Acute kidney injury (AKI), which is common among Human immunodeficiency virus (HIV)-positive individuals, may contribute to the excess burden of chronic kidney disease (CKD) in this patient population; conventional clinical methods to detect AKI do not capture kidney injury sufficiently early to prevent irreversible damage
These findings suggest that HIV-positive individuals may sustain extensive kidney injury that is not fully captured by currently available clinical methods, such as serum creatinine, to detect AKI and measure its severity
We further postulate that higher urine biomarker levels of kidney injury during hospitalization are predictive of longitudinal kidney function decline
Summary
Acute kidney injury (AKI), which is common among HIV-positive individuals, may contribute to the excess burden of chronic kidney disease (CKD) in this patient population; conventional clinical methods to detect AKI do not capture kidney injury sufficiently early to prevent irreversible damage. In the modern era of effective antiretroviral therapy, HIV-positive individuals remain at increased risk of developing chronic kidney disease (CKD) and progressing to end-stage renal disease (ESRD). Corona-Villalobos et al BMC Nephrology (2017) 18:289 among patients who return to their baseline serum creatinine, the risk of progression to ESRD and death remain significantly elevated These findings suggest that HIV-positive individuals may sustain extensive kidney injury that is not fully captured by currently available clinical methods, such as serum creatinine, to detect AKI and measure its severity. The current national guidelines define AKI based on absolute and relative increases in serum creatinine and/ or declines in urine output, these parameters may not be altered until over half of kidney function has been lost Given these limitations, many individuals may sustain critical kidney damage despite serum creatinine levels and urine output remaining unchanged. We further postulate that higher urine biomarker levels of kidney injury during hospitalization are predictive of longitudinal kidney function decline
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