A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury
University of California, San Francisco
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.
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 asso…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
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.
Location
- University of California, San FranciscoSan Francisco, California