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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: Medication reconciliation; Other: Blood Pressure Management

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of incorrectly prescribed medicines	The number of incorrectly dosed or prescribed medications that are detected or changed	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.	90 days
Blood pressure control	Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.	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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	90 days

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Vanderbilt University Medical Center; University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): October 11, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: IRB-161201002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No