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Completed

NCT Number: NCT04358874

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medication reconciliation

Other

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

Blood Pressure Management

Other

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

Primary outcomes

  1. Number of incorrectly prescribed medicines

    Time frame: 90 days

    The number of incorrectly dosed or prescribed medications that are detected or changed

  2. Proportion of individuals restarting RAAS inhibitors

    Time frame: 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.

  3. Blood pressure control

    Time frame: 90 days

    Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.

  4. Recovery of kidney function

    Time frame: 90 days

    Proportion of individuals who have recovered from AKI, defined as a serum creatinine within 10% of baseline by 3 months

Secondary outcomes

  1. Major adverse kidney outcomes

    Time frame: 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%.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • University of Kentucky
  • Vanderbilt University Medical Center

Registry information

Acronym: MAKE-IT

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Apr 24, 2020
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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