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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT04358874

Collaborator

Vanderbilt University Medical Center (Other), University of Kentucky (Other)

120

Enrollment

Locations

Arms

23.5

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Other: Medication reconciliation Other: Blood Pressure Management	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 14, 2020

Actual Primary Completion Date :

Oct 11, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: Medication reconciliation Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge. 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)
Active Comparator: 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.	Other: Medication reconciliation Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge. 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)

Arm

Intervention/Treatment

Experimental: 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

Other: Medication reconciliation

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

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)

Active Comparator: 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.

Other: Medication reconciliation

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

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)

Outcome Measures

Primary Outcome Measures

Number of incorrectly prescribed medicines [90 days]
The number of incorrectly dosed or prescribed medications that are detected or changed
Proportion of individuals restarting RAAS inhibitors [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.
Blood pressure control [90 days]
Systolic and diastolic blood pressure obtained by automatic blood pressure cuff in the clinic.
Recovery of kidney function [90 days]
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 [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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	University of Kentucky	Lexington	Kentucky	United States	40508
3	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

University of Alabama at Birmingham
Vanderbilt University Medical Center
University of Kentucky

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orlando M. Gutierrez, MD, MMSc, Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04358874

Other Study ID Numbers:

IRB-161201002

First Posted:

Apr 24, 2020

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Study Results

No Results Posted as of Jun 14, 2022