title: Design of Clinical Trials in Acute Kidney Injury: Lessons from the Past and Future Directions.
abstract: Acute kidney injury (AKI) is a common condition with multiple etiologies and variable clinical findings and pathologic manifestations. AKI is associated with serious adverse clinical outcomes, including the development of de novo chronic kidney disease, accelerated progression of pre-existing chronic kidney disease, end-stage kidney disease, and increased mortality. Past research has advanced our understanding of the pathophysiology, epidemiology, and outcomes of AKI significantly, however, little progress has been made in the development of evidence-based interventions for its prevention and treatment. In this review, we discuss key considerations in the design of clinical trials in AKI and highlight significant methodologic limitations that precluded many past studies from determining the effectiveness of preventive and therapeutic strategies for this common and serious condition.
authors.affiliation: Renal Section, VA Pittsburgh Healthcare System, Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA. Electronic address: weisbordsd@upmc.edu.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Weisbord
authors.affiliation: Renal Section, VA Pittsburgh Healthcare System, Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Palevsky
mesh_terms: D058186:Acute Kidney Injury / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000458:organization & administration*; D019468:Disease Management; D006801:Humans
keywords: Acute kidney injury; clinical trial; prevention; treatment