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

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Other: Medication reconciliation; Other: Blood Pressure Management

• Registration Number: NCT04358874
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Study Start: 2020-10-14
• Primary Completion: 2021-10-11
• Status Verified: 2024-12
• Study Completion: 2024-12-16
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual follow-up	Blood Pressure Management	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.
Active follow-up	Medication reconciliation	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
Active follow-up	Blood Pressure Management	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
Usual follow-up	Medication reconciliation	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.

Primary Outcome Measures

Name	Time	Method
Recovery of kidney function	90 days	Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months
Number of incorrectly prescribed medicines	90 days	The number of incorrectly dosed or prescribed medications that are detected or changed
Proportion of individuals restarting RAAS inhibitors	90 days	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.
Blood pressure control	90 days	Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.

Secondary Outcome Measures

Name	Time	Method
Major adverse kidney outcomes	90 days	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%.

Trial Locations

Locations (3)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States