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

NCT ID: NCT04358874

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2024-12-16

Brief Summary

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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

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Medication reconciliation

Intervention Type OTHER

Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.

Blood Pressure Management

Intervention Type OTHER

Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (\>160/100)

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.

Group Type ACTIVE_COMPARATOR

Medication reconciliation

Intervention Type OTHER

Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.

Blood Pressure Management

Intervention Type OTHER

Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (\>160/100)

Interventions

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Medication reconciliation

Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Orlando M. Gutierrez, MD, MMSc

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-161201002

Identifier Type: -

Identifier Source: org_study_id