Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study

University of Alabama at Birmingham20 enrolled

Overview

This purpose of this pilot and feasibility study is to determine whether attending an acute kidney injury (AKI) clinic after discharge from the hospital impacts prescription medicine use, blood pressure and recovery of kidney function as compared to usual care.

Participants with moderate to severe acute kidney injury (AKI) who are discharged from participating centers (the University of Alabama at Birmingham Hospital, Vanderbilt University Medical Center, University of Kentucky) will be randomized to coming to a dedicated AKI clinic at one of the three recruitment centers for up to four visits over 3 months or usual care. At the visits to the AKI follow-up clinics, medicine reconciliation will be done, blood pressure will be measured, information on hospitalizations and other adverse events will be taken and blood and urine samples will be collected to check kidney function and store samples to measure biomarkers of AKI. Participants randomized to usual care will be contacted by telephone to review medications currently being taken and to collect information on hospitalizations and other adverse events. The primary outcome measures will be include both process of care and clinical outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Kidney Injury

Interventions

Medication reconciliationOTHER

Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.

Blood Pressure ManagementOTHER

Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (\>160/100)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients age 18 years and older * Patients who have developed moderate to severe AKI in the hospital, defined as: 1. At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital 2. AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate \< 60 ml/min/1.73m2 at baseline 3. AKI of any degree whose discharge creatinine does not return to within 50% of baseline. * Able to provide signed informed consent Exclusion Criteria: * Patients with a history of kidney transplant * Patients who, in the opinion of the investigator, are not suitable to participate in the study * Unable to obtain written informed consent * prisoners or pregnant patients

Locations (3)

University of Alabama

Birmingham, Alabama, United States

University of Kentucky

Lexington, Kentucky, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of incorrectly prescribed medicines

The number of incorrectly dosed or prescribed medications that are detected or changed

Time frame: 90 days

Proportion of individuals restarting RAAS inhibitors

Proportion of patients with a class I indication for renin-angiotensin-aldosterone (RAAS) inhibitors who have appropriately re-started RAAS inhibitors within 3 months of discharge.

Time frame: 90 days

Blood pressure control

Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.

Time frame: 90 days

Recovery of kidney function

Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months

Time frame: 90 days

Secondary Outcomes

Major adverse kidney outcomes

Defined as a composite of death, need for new dialysis, rehospitalization for AKI, recurrent AKI, or a persistent increase in baseline serum creatinine of ≥ 50%.

Time frame: 90 days

Data from ClinicalTrials.gov

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