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

The University of Alabama at Birmingham

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Other: Medication reconciliation; Other: Blood Pressure Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04358874

IRB-161201002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Active follow-up

Experimental group

Description:

Participants randomized to the active follow-up arm will have follow-up visits in the AKI follow-up clinic every 4 weeks after discharge for a total of 90 days after discharge

Treatment:

Other: Blood Pressure Management

Other: Medication reconciliation

Usual follow-up

Active Comparator group

Description:

Participants randomized to the usual follow-up arm will be called at home 4 weeks after the baseline visit to collect information on primary and secondary outcomes.

Treatment:

Other: Blood Pressure Management

Other: Medication reconciliation