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Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery (ASPIRE-85)

22 agosto 2026 aggiornato da: Universitätsklinikum Hamburg-Eppendorf

Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery: the Multicenter Randomized ASPIRE-85 Trial

In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

3432

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Karim Kouz, MD
  • Numero di telefono: +4940741052415
  • Email: k.kouz@uke.de

Backup dei contatti dello studio

  • Nome: Bernd Saugel, MD
  • Numero di telefono: +4940741052415
  • Email: b.saugel@uke.de

Luoghi di studio

  • Germania
      • Hamburg, Germania
        • Reclutamento
        • • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg
        • Contatto:
          • Karim Kouz, MD
          • Numero di telefono: +4940741052415
          • Email: k.kouz@uke.de

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

To be eligible for trial inclusion, patients must:

  • 1) be able to provide informed consent, AND
  • 2) be ≥65 years old, AND
  • 3) be scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥120 minutes, AND
  • 4) have chronic arterial hypertension requiring antihypertensive medication OR have a systolic arterial pressure ≥140 mmHg or diastolic arterial pressure ≥90 mmHg on a measurement performed within the previous year, AND
  • 5) be at high risk for postoperative delirium because: American Society of Anesthesiologists physical status class III or IV OR Charlson Comorbidity Index ≥3 points (please see Appendix 1) OR frailty (documented in medical records or clinical diagnosis)

Exclusion Criteria:

Patients that meet one or more of the following exclusion criteria cannot participate in the trial:

  • solid organ transplant surgery
  • intracranial surgery
  • surgery in sitting position
  • sepsis
  • surgery in the previous 30 days
  • previous participation in ASPIRE-85

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: MAP at 85 mmHg or higher (intervention group)
In patients assigned to the intervention group, clinicians will be instructed to maintain MAP at 85 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and end at the end of surgery.
Altro: MAP at 85 mmHg or higher (intervention group)
In patients assigned to the intervention group, clinicians will be instructed to maintain MAP at 85 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.
Altro: MAP at 65 mmHg or higher (control group)
In patients assigned to the control group, clinicians will be instructed to maintain MAP at 65 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and end at the end of surgery.
Altro: MAP at 65 mmHg or higher (control group)
In patients assigned to the control group, clinicians will be instructed to maintain MAP at 65 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Delirium within the first 3 postoperative days (binary outcome)
Lasso di tempo: within the first 3 postoperative days
Delirium will be assessed on the day of surgery after transfer from the post-anesthesia care unit to the general ward or intensive care unit and twice daily on postoperative days 1, 2, and 3. The 3-Minute Diagnostic Confusion Assessment Method will be used for patients on general wards and the Confusion Assessment Method for the Intensive Care Unit for patients in intensive care units.
within the first 3 postoperative days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Days patients have delirium within the first 3 postoperative days (count outcome)
Lasso di tempo: within the first 3 postoperative days
within the first 3 postoperative days
Delirium within the first 7 postoperative days (binary outcome)
Lasso di tempo: within the first 7 postoperative days
Delirium will be based on systematic delirium assessments through postoperative day 3 and routine clinical screening from postoperative days 4 to 7.
within the first 7 postoperative days
Acute kidney injury within the first 7 postoperative days (binary outcome)
Lasso di tempo: within the first 7 postoperative days
Acute kidney injury will be defined as an increase in serum creatinine of ≥50% from baseline or need for renal replacement therapy.
within the first 7 postoperative days
Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)
Lasso di tempo: within the first 7 postoperative days
Acute myocardial injury (Fourth Universal Definition 2018) will be defined as an increase in high-sensitivity troponin according to the definition of "myocardial injury and infarction associated with non-cardiac procedures" set forth in the Fourth Universal Definition of Myocardial Infarction (2018).
within the first 7 postoperative days
Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)
Lasso di tempo: within the first 7 postoperative days
Acute myocardial injury (latest definition at time of analysis) will be defined according to the latest applicable universal definition available at the time of the final analysis; this definition will be prespecified in the statistical analysis plan before database lock and unblinding.
within the first 7 postoperative days
Stroke within the first 7 postoperative days (binary outcome)
Lasso di tempo: within the first 7 postoperative
Stroke will be defined as any documented diagnosis of stroke in the medical record.
within the first 7 postoperative
Days alive and out of hospital within the first 90 postoperative days (count outcome)
Lasso di tempo: within the first 90 postoperative days
Days alive and out of hospital within the first 90 postoperative days will be defined as the number of days patients are alive and not hospitalized during the first 90 days after surgery. Patients who die within 90 days will be assigned 0 days alive and out of hospital.
within the first 90 postoperative days
Time until all-cause death within the first 90 postoperative days (time-to-event outcome)
Lasso di tempo: within the first 90 postoperative days
Time to all-cause death within 90 postoperative days will be defined as the time from surgery to death from any cause. Patients alive at 90 days will be censored at 90 days.
within the first 90 postoperative days
Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome)
Lasso di tempo: within the first 90 postoperative days
Time to hospital discharge within 90 postoperative days will be defined as the time from surgery to hospital discharge; patients not discharged will be censored at death, trial withdrawal, or 90 days, whichever occurs first.
within the first 90 postoperative days
Long-term cognitive function at postoperative day 180 (continuous outcome)
Lasso di tempo: postoperative day 180
Long-term cognitive function will be assessed before surgery and at postoperative day 180 using the 5-minute Montreal Cognitive Assessment (minimal score: 0 points, maximal score: 15 points; with higher scores indicating better cognitive function).
postoperative day 180
Quality of recovery at postoperative day 2 (continuous outcome)
Lasso di tempo: postoperative day 2
Quality of recovery will be assessed before surgery and 48 hours after surgery using the Quality of Recovery-15 questionnaire (minimal score: 0 points, maximal score: 150 points; with higher scores indicating better quality of recovery).
postoperative day 2
Quality of life at postoperative day 180 (visual analog scale; continuous outcome)
Lasso di tempo: postoperative day 180
Quality of life will be assessed before surgery and at postoperative day 180 using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire (visual analog scale; minimal score: 0, maximal score: 100; with higher scores indicating better quality of life).
postoperative day 180
Quality of life at postoperative day 180 (index value; continuous outcome)
Lasso di tempo: postoperative day 180
Quality of life will be assessed before surgery and at postoperative day 180 using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire (index value using the German population value set; maximal score: 1.000; with higher scores indicating better quality of life).
postoperative day 180

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaboratori

Germany's Federal Ministry of Research, Technology and Space (BMFTR)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 agosto 2026

Completamento primario (Stimato)

1 ottobre 2029

Completamento dello studio (Stimato)

1 settembre 2030

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-101764-BO-ff

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Upon reasonable written request, pseudonymized patient data may be shared with researchers who provide a methodologically sound proposal. Data will be shared only for analyses consistent with the approved proposal and after approval by the trial steering committee and execution of a data sharing agreement.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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