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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yuenting D Kwong, MD MAS
- Número de teléfono: 415-514-7371
- Correo electrónico: diana.kwong@ucsf.edu
Ubicaciones de estudio
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- Reclutamiento
- University of California, San Francisco
-
Contacto:
- Yuenting D Kwong, MD MAS
- Número de teléfono: 415-514-7371
- Correo electrónico: diana.kwong@ucsf.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Usual care
RASi restart will be deferred to the study participant's providers.
|
RASi restart will be deferred to the study participant's providers.
|
|
Experimental: 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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility- RASi use separation
Periodo de tiempo: 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
|
From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tolerability- 90 day follow up completion
Periodo de tiempo: Up to 90 days
|
Proportion of participants who complete 90 day follow up
|
Up to 90 days
|
|
Tolerability- Lab evaluation post RASi
Periodo de tiempo: 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
|
Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital
|
|
Tolerability- SCr evaluation after hospital discharge
Periodo de tiempo: Up to 90 days
|
Proportion with SCr evaluation after hospital discharge
|
Up to 90 days
|
|
Tolerability- Proteinuria evaluation
Periodo de tiempo: Up to 90 days
|
Proportion with proteinuria evaluation after hospital discharge
|
Up to 90 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening-to-recruitment ratio
Periodo de tiempo: Total study duration, anticipated 2.5 years, up to 4 years total
|
Number of patients screened divided by the number of patients enrolled
|
Total study duration, anticipated 2.5 years, up to 4 years total
|
|
Adverse events
Periodo de tiempo: Up to 90 days
|
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
|
Up to 90 days
|
|
90 day RASi use
Periodo de tiempo: Up to 90 days
|
Proportion with RASi use at 90 days
|
Up to 90 days
|
|
Cumulative RASi exposure
Periodo de tiempo: Up to 90 days
|
Number of days with RASi use
|
Up to 90 days
|
|
Days to RASi restart
Periodo de tiempo: Up to 90 days
|
Days to RASi restart from day of peak SCr
|
Up to 90 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yuenting D Kwong, MD MAS, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-45052
- K23DK139456 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .