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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Yuenting D Kwong, MD MAS
- 전화번호: 415-514-7371
- 이메일: diana.kwong@ucsf.edu
연구 장소
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California
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San Francisco, California, 미국, 94143
- 모병
- University of California, San Francisco
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연락하다:
- Yuenting D Kwong, MD MAS
- 전화번호: 415-514-7371
- 이메일: diana.kwong@ucsf.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility- RASi use separation
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tolerability- 90 day follow up completion
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Screening-to-recruitment ratio
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Yuenting D Kwong, MD MAS, University of California, San Francisco
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-45052
- K23DK139456 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
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