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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active follow-up 		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
  • Other: Medication reconciliation
    Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
  • Other: Blood Pressure Management
    Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)
Active Comparator
Usual follow-up 		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.
  • Other: Medication reconciliation
    Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
  • Other: Blood Pressure Management
    Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)

Recruiting Locations

More Details

NCT ID
NCT04358874
Status
Active, not recruiting
Sponsor
University of Alabama at Birmingham

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.