Acute Kidney Injury
Conditions
Keywords
Acute kidney injury
Brief summary
The goal of this pilot clinical trial is to learn if early restart of renin-angiotensin system inhibitor (RASi) medications is feasible and well-tolerated in hospitalized patients with acute kidney injury (AKI). Researchers will compare early RASi restart to usual care. Study participants will restart RASi per study protocol, obtain a lab test in 1-2 weeks if RASi restarted in the hospital and not collected as part of routine care, and answer questions at the 90-day follow-up.
Detailed description
Among at-risk patients with heart failure and chronic kidney disease, use of RASi medications decreases the subsequent risk of adverse events such as cardiovascular death and kidney disease progression. However, RASi treatment is often stopped when AKI is detected in the hospital based on the notion that restoring an intact renin-angiotensin system in the context of hypovolemia or hypotension may be helpful to maintain perfusion to the glomeruli and thus support the glomerular filtration rate. In observational studies, restart of RASi medications among at-risk patients after AKI has been associated with decreased subsequent rates of mortality, cardiovascular events, and kidney disease progression. However, there is no rigorous evidence from randomized trials to guide optimal strategy of RASi restart after AKI. This is a pilot trial among hospitalized patients with AKI whose RASi were held to investigate the feasibility and tolerability of a strategy of early RASi restart (n=30) compared to usual care (n=30). This pilot trial will provide valuable data critical to inform the design of a larger definitive trial. The study hypothesis is that the strategy of early RASi restart after AKI is feasible and well-tolerated. This pilot trial will inform the design of a larger definitive trial to determine whether early RASi restart can increase rates of RASi use at 90 days compared to usual care.
Interventions
DRUGEarly RASi restart strategy
The early restart strategy is to resume RASi as soon as the serum creatinine (SCr) downtrends by ≥0.3mg/dL from peak. In addition, the following criteria must be met: most recent potassium ≤5mEq/L, CKD-EPI SCr-based eGFR reported as ≥15 mL/min/1.73m2, and average SBP ≥120mmHg 12 hours prior to restart. If the study participant is discharged from the hospital before the RASi restart criteria are met, management of RASi restart would be deferred to the discretion of longitudinal outpatient healthcare team.
DRUGUsual Care
RASi restart will be deferred to the study participant's providers.
Sponsors
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot 2-arm parallel-comparison randomized clinical trial comparing early RASi restart strategy to usual care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Pre-admission RASi use for Class I indication (e.g., heart failure, kidney disease) * RASi stopped in the setting of AKI (defined by ≥1.5x baseline SCr) * AKI in recovery (defined by a decrease in SCr by ≥0.3mg/dL from peak)
Exclusion criteria
* RASi allergy or contraindication (i.e., angioedema, bilateral renal artery stenosis) * Ongoing dialysis requirement * Pregnant or breastfeeding * Prisoner * Palliative or hospice care involvement * Unable to consent * No enteral route of medication administration * Clinician judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility- RASi use separation | From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital | Proportion of patients in the early RASi restart arm and the usual care arm who restart RASi within 72 hours of SCr downtrending by ≥0.3mg/dL from peak SCr and at hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability- 90 day follow up completion | Up to 90 days | Proportion of participants who complete 90 day follow up |
| Tolerability- SCr evaluation after hospital discharge | Up to 90 days | Proportion with SCr evaluation after hospital discharge |
| Tolerability- Proteinuria evaluation | Up to 90 days | Proportion with proteinuria evaluation after hospital discharge |
| Tolerability- Lab evaluation post RASi | Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital | Proportion with potassium and SCr evaluations within 1-2 weeks of RASi restart |
Countries
United States
Contacts
CONTACTYuenting D Kwong, MD MAS
PRINCIPAL_INVESTIGATORYuenting D Kwong, MD MAS
University of California, San Francisco
Outcome results
None listed