Clinical trial NCT04358874: Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
Official title: Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: University of Kentucky
First posted: 2020-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of incorrectly prescribed medicines
timeFrame: 90 days
measure: Proportion of individuals restarting RAAS inhibitors
timeFrame: 90 days
measure: Blood pressure control
timeFrame: 90 days
measure: Recovery of kidney function
timeFrame: 90 days
Secondary outcomes:
measure: Major adverse kidney outcomes
timeFrame: 90 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References: