A Prompt REstart Study of Renin-Angiotensin System Inhibitors After Acute Kidney Injury

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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, 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 healthc
• Препарат Usual Care
  RASi restart will be deferred to the study participant's providers.

Первичные конечные точки

• Feasibility- RASi use separation [Срок оценки: From date of enrollment until date of hospital discharge or up to 90 days if remains in the hospital]

Вторичные конечные точки (4)

• Tolerability- 90 day follow up completion [Срок оценки: Up to 90 days]
• Tolerability- Lab evaluation post RASi [Срок оценки: Up to 2 weeks post hospital discharge or 90 days if patient remains in the hospital]
• Tolerability- SCr evaluation after hospital discharge [Срок оценки: Up to 90 days]
• Tolerability- Proteinuria evaluation [Срок оценки: Up to 90 days]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07734636 · 25-45052 · K23DK139456

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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