Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI)

General Description

The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study investigates differences in the occurrence of renal and cardiovascular outcomes and death within a diverse, matched cohort of patients with and without acute kidney injury (AKI). This prospective study enrolls a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at 3 Clinical Research Centers, as well as 100 children undergoing cardiac surgery at 3 Clinical Research Centers. Participants are followed for up to four years, and undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens are collected at each visit, in addition to information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography, and urinalysis.

Objectives

The primary goals of the ASSESS-AKI study are to characterize the short-term and long-term natural history of AKI, evaluate the incremental utility of novel blood and urine biomarkers to refine the diagnosis and prognosis of AKI, and identify a subset of high-risk patients who could be targeted for future clinical trials to improve outcomes after AKI.

Outcome Measure

Renal outcomes (including change in kidney function, time to development of incident CKD, progression of CKD, development of ESRD, and incident or recurrent episodes of AKI), cardiovascular outcomes (including coronary heart disease, heart failure, and arrhythmias and ECG abnormalities), cebrovascular outcomes, peripheral arterial disease outcomes, and mortality will be monitored.

Criteria

Participants are divided into two groups: adult (aged 18 years to 89 years) and children (aged greater than 1 month to less than 18 years). To participate, all patients must have a documented baseline serum creatinine value, which is then used to estimate glomerular filtration rate (eGFR). For hospitalized patients, baseline serum creatinine is defined as the outpatient, non-emergency department test value nearest to the index hospitalization within 7 and 365 days prior to admission using an IDMS-traceable serum creatinine assay; for patients undergoing surgery, this baseline value is defined as pre-operative serum creatinine results from an IDMS-traceable assay obtained within seven days before cardiac surgery. For pediatric participants, a pre-operative serum creatinine concentration measured in the local hospital clinical laboratory can be used as a baseline.

Outcome

This study is ongoing.