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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. august 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3432

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Karim Kouz, MD
  • Telefonnummer: +4940741052415
  • E-mail: k.kouz@uke.de

Undersøgelse Kontakt Backup

  • Navn: Bernd Saugel, MD
  • Telefonnummer: +4940741052415
  • E-mail: b.saugel@uke.de

Studiesteder

  • Tyskland
      • Hamburg, Tyskland
        • Rekruttering
        • • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg
        • Kontakt:
          • Karim Kouz, MD
          • Telefonnummer: +4940741052415
          • E-mail: k.kouz@uke.de

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delirium within the first 3 postoperative days (binary outcome)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Days patients have delirium within the first 3 postoperative days (count outcome)
Tidsramme: within the first 3 postoperative days
within the first 3 postoperative days
Delirium within the first 7 postoperative days (binary outcome)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. august 2026

Primær færdiggørelse (Anslået)

1. oktober 2029

Studieafslutning (Anslået)

1. september 2030

Datoer for studieregistrering

Først indsendt

28. juni 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-101764-BO-ff

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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