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

NCT04358874 | Completed DMC

• 1 other identifier: IRB-161201002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Major adverse kidney outcomes

  90 days

Study Arms (2)

Active follow-up

EXPERIMENTAL

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; Other: Blood Pressure Management

Usual follow-up

ACTIVE COMPARATOR

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; Other: Blood Pressure Management

Interventions

Medication reconciliation OTHER

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

Active follow-up; Usual follow-up

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)

Active follow-up; Usual follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Vanderbilt University Medical Center: collaborator
• University of Kentucky: collaborator

Study Sites (3)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Medication Reconciliation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: October 14, 2020
• Primary Completion: October 11, 2021
• Study Completion: December 16, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)