A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury (APRES-AKI)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Yuenting D Kwong, MD MAS
- Telefoonnummer: 415-514-7371
- E-mail: diana.kwong@ucsf.edu
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94143
- Werving
- University of California, San Francisco
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Contact:
- Yuenting D Kwong, MD MAS
- Telefoonnummer: 415-514-7371
- E-mail: diana.kwong@ucsf.edu
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Usual care
RASi restart will be deferred to the study participant's providers.
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RASi restart will be deferred to the study participant's providers.
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Experimenteel: Early 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, SCr-based eGFR reported as ≥15 mL/min/1.73m2,
and average systolic blood pressure≥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.
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility- RASi use separation
Tijdsspanne: From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital
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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
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From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tolerability- 90 day follow up completion
Tijdsspanne: Up to 90 days
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Proportion of participants who complete 90 day follow up
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Up to 90 days
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Tolerability- Lab evaluation post RASi
Tijdsspanne: Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital
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Proportion with potassium and SCr evaluations within 1-2 weeks of RASi restart
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Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital
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Tolerability- SCr evaluation after hospital discharge
Tijdsspanne: Up to 90 days
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Proportion with SCr evaluation after hospital discharge
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Up to 90 days
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Tolerability- Proteinuria evaluation
Tijdsspanne: Up to 90 days
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Proportion with proteinuria evaluation after hospital discharge
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Up to 90 days
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Screening-to-recruitment ratio
Tijdsspanne: Total study duration, anticipated 2.5 years, up to 4 years total
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Number of patients screened divided by the number of patients enrolled
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Total study duration, anticipated 2.5 years, up to 4 years total
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Adverse events
Tijdsspanne: Up to 90 days
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Total number of adverse events and number of adverse events attributable to study intervention.
Adverse events include: hyperkalemia (>5.5mEq/L and >6mEq/L), recurrent AKI (minor (30-<50% decline) versus major (>=50% decline) in eGFR), symptomatic hypotension or hypertension, emergency room visits, hospitalizations, increase index hospital length of stay
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Up to 90 days
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90 day RASi use
Tijdsspanne: Up to 90 days
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Proportion with RASi use at 90 days
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Up to 90 days
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Cumulative RASi exposure
Tijdsspanne: Up to 90 days
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Number of days with RASi use
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Up to 90 days
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Days to RASi restart
Tijdsspanne: Up to 90 days
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Days to RASi restart from day of peak SCr
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Up to 90 days
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Yuenting D Kwong, MD MAS, University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25-45052
- K23DK139456 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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