Trial Outcomes & Findings for A Study of Acute Kidney Injury in Care Transitions (NCT NCT05184894)
NCT ID: NCT05184894
Last Updated: 2024-12-18
Results Overview
Total number of subjects to complete the full ACT program intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
30 days after hospitalization
Results posted on
2024-12-18
Participant Flow
Eligible patients were identified using an electronic health record (EHR)- embedded list of adults (≥18 years) hospitalized at Mayo Clinic in Rochester from January 2022 to July 2023 who met stage 3 AKI criteria based on serum creatinine rise or urine output decline during a hospitalization and had a local address. Candidate participants were approached within 48-72 hours of discharge to obtain written informed consent and randomized 1:1 to the ACT intervention or usual care.
Participant milestones
| Measure |
AKI in Care Transitions (ACT) Group
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay.
AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
|
Usual Care Group
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Acute Kidney Injury in Care Transitions
Baseline characteristics by cohort
| Measure |
AKI in Care Transitions (ACT) Group
n=25 Participants
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay.
AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
|
Usual Care Group
n=25 Participants
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will receive standard of care from their inpatient and outpatient care teams.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=99 Participants
|
66 years
n=107 Participants
|
65 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Caucasian
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other or Unknown Race/Ethnicity
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Preadmission baseline eGFR
|
63 mL/min/1.73m^2
n=99 Participants
|
61 mL/min/1.73m^2
n=107 Participants
|
62 mL/min/1.73m^2
n=206 Participants
|
|
Discharge eGFR
|
31 mL/min/1.73m^2
n=99 Participants
|
27 mL/min/1.73m^2
n=107 Participants
|
30 mL/min/1.73m^2
n=206 Participants
|
|
AKI Recovery stage at discharge
Recovered (back to baseline) or stage 0 recovery (serum creatinine < 1.5x baseline)
|
17 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
AKI Recovery stage at discharge
Stage 1 recovery (1.5-1.9x baseline)
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
AKI Recovery stage at discharge
Stage 2 recovery (2.0-2.9x baseline)
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
AKI Recovery stage at discharge
Stage 3 recovery (3x baseline or >= 4 mg/dL)
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 days after hospitalizationTotal number of subjects to complete the full ACT program intervention
Outcome measures
| Measure |
AKI in Care Transitions (ACT) Group
n=25 Participants
Subjects diagnosed with Acute Kidney Injury (AKI) during their hospital stay will participate in the ACT program which provides standardized education and assists with coordination of follow up care after hospital stay.
AKI in Care Transitions (ACT) program: Multicomponent transitional support bundle that includes consultation from nurse educators before discharge to deliver kidney health education and coordination of appointments post-discharge.
|
|---|---|
|
Number of Subjects to Complete the ACT Program
|
22 Participants
|
Adverse Events
AKI in Care Transitions (ACT) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place