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

Acute Kidney Injury Clinical Trial

— MAKE-IT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04358874
• Other study ID #: IRB-161201002
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• Medication reconciliation
Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
• 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)

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of Kentucky	Lexington	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University of Kentucky, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of incorrectly prescribed medicines	The number of incorrectly dosed or prescribed medications that are detected or changed	90 days
Primary	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
Primary	Blood pressure control	Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.	90 days
Primary	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	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%.	90 days