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

Primary Purpose

Acute Kidney Injury

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medication reconciliation
Blood Pressure Management
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama
  • University of Kentucky
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active follow-up

Usual follow-up

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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%.

Full Information

First Posted
April 20, 2020
Last Updated
June 12, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Vanderbilt University Medical Center, University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT04358874
Brief Title
Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
Acronym
MAKE-IT
Official Title
Maximizing Acute Kidney Injury End-point Intervention Post-Discharge (MAKE-IT) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Vanderbilt University Medical Center, University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active follow-up
Arm Type
Experimental
Arm 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
Arm Title
Usual follow-up
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Medication reconciliation
Intervention Description
Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
Intervention Type
Other
Intervention Name(s)
Blood Pressure Management
Intervention Description
Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)
Primary Outcome Measure Information:
Title
Number of incorrectly prescribed medicines
Description
The number of incorrectly dosed or prescribed medications that are detected or changed
Time Frame
90 days
Title
Proportion of individuals restarting RAAS inhibitors
Description
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.
Time Frame
90 days
Title
Blood pressure control
Description
Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.
Time Frame
90 days
Title
Recovery of kidney function
Description
Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Major adverse kidney outcomes
Description
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%.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients age 18 years and older Patients who have developed moderate to severe AKI in the hospital, defined as: At least a doubling of peak creatinine from baseline or receipt of dialysis while in the hospital AKI of any degree in individuals with an estimated glomerular filtration (eGFR) rate < 60 ml/min/1.73m2 at baseline 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
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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