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)
2026년 8월 22일 업데이트: 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
3432
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Karim Kouz, MD
- 전화번호: +4940741052415
- 이메일: k.kouz@uke.de
연구 연락처 백업
- 이름: Bernd Saugel, MD
- 전화번호: +4940741052415
- 이메일: b.saugel@uke.de
연구 장소
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Hamburg, 독일
- 모병
- • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg
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연락하다:
- Karim Kouz, MD
- 전화번호: +4940741052415
- 이메일: k.kouz@uke.de
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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다른: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Delirium within the first 3 postoperative days (binary outcome)
기간: within the first 3 postoperative days
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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.
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within the first 3 postoperative days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Days patients have delirium within the first 3 postoperative days (count outcome)
기간: within the first 3 postoperative days
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within the first 3 postoperative days
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Delirium within the first 7 postoperative days (binary outcome)
기간: within the first 7 postoperative days
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Delirium will be based on systematic delirium assessments through postoperative day 3 and routine clinical screening from postoperative days 4 to 7.
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within the first 7 postoperative days
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Acute kidney injury within the first 7 postoperative days (binary outcome)
기간: within the first 7 postoperative days
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Acute kidney injury will be defined as an increase in serum creatinine of ≥50% from baseline or need for renal replacement therapy.
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within the first 7 postoperative days
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Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)
기간: within the first 7 postoperative days
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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).
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within the first 7 postoperative days
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Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)
기간: within the first 7 postoperative days
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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.
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within the first 7 postoperative days
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Stroke within the first 7 postoperative days (binary outcome)
기간: within the first 7 postoperative
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Stroke will be defined as any documented diagnosis of stroke in the medical record.
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within the first 7 postoperative
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Days alive and out of hospital within the first 90 postoperative days (count outcome)
기간: within the first 90 postoperative days
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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.
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within the first 90 postoperative days
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Time until all-cause death within the first 90 postoperative days (time-to-event outcome)
기간: within the first 90 postoperative days
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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.
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within the first 90 postoperative days
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Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome)
기간: within the first 90 postoperative days
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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.
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within the first 90 postoperative days
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Long-term cognitive function at postoperative day 180 (continuous outcome)
기간: postoperative day 180
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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).
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postoperative day 180
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Quality of recovery at postoperative day 2 (continuous outcome)
기간: postoperative day 2
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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).
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postoperative day 2
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Quality of life at postoperative day 180 (visual analog scale; continuous outcome)
기간: postoperative day 180
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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).
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postoperative day 180
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Quality of life at postoperative day 180 (index value; continuous outcome)
기간: postoperative day 180
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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).
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postoperative day 180
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 21일
기본 완료 (추정된)
2029년 10월 1일
연구 완료 (추정된)
2030년 9월 1일
연구 등록 날짜
최초 제출
2026년 6월 28일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 22일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-101764-BO-ff
개별 참가자 데이터(IPD) 계획
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예
IPD 계획 설명
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
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