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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Yuenting D Kwong, MD MAS
- Número de telefone: 415-514-7371
- E-mail: diana.kwong@ucsf.edu
Locais de estudo
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California
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San Francisco, California, Estados Unidos, 94143
- Recrutamento
- University of California, San Francisco
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Contato:
- Yuenting D Kwong, MD MAS
- Número de telefone: 415-514-7371
- E-mail: diana.kwong@ucsf.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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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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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility- RASi use separation
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Tolerability- 90 day follow up completion
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Screening-to-recruitment ratio
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yuenting D Kwong, MD MAS, University of California, San Francisco
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 25-45052
- K23DK139456 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
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