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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Yuenting D Kwong, MD MAS
- Numero di telefono: 415-514-7371
- Email: diana.kwong@ucsf.edu
Luoghi di studio
-
-
California
-
San Francisco, California, Stati Uniti, 94143
- Reclutamento
- University of California, San Francisco
-
Contatto:
- Yuenting D Kwong, MD MAS
- Numero di telefono: 415-514-7371
- Email: diana.kwong@ucsf.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Usual care
RASi restart will be deferred to the study participant's providers.
|
RASi restart will be deferred to the study participant's providers.
|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility- RASi use separation
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tolerability- 90 day follow up completion
Lasso di tempo: Up to 90 days
|
Proportion of participants who complete 90 day follow up
|
Up to 90 days
|
|
Tolerability- Lab evaluation post RASi
Lasso di tempo: 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
Lasso di tempo: Up to 90 days
|
Proportion with SCr evaluation after hospital discharge
|
Up to 90 days
|
|
Tolerability- Proteinuria evaluation
Lasso di tempo: Up to 90 days
|
Proportion with proteinuria evaluation after hospital discharge
|
Up to 90 days
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Screening-to-recruitment ratio
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 90 days
|
Proportion with RASi use at 90 days
|
Up to 90 days
|
|
Cumulative RASi exposure
Lasso di tempo: Up to 90 days
|
Number of days with RASi use
|
Up to 90 days
|
|
Days to RASi restart
Lasso di tempo: Up to 90 days
|
Days to RASi restart from day of peak SCr
|
Up to 90 days
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Yuenting D Kwong, MD MAS, University of California, San Francisco
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 25-45052
- K23DK139456 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .