카페인, 수술 후 섬망 및 수술 후 결과의 변화(CAPACHINOS-2) 연구
The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.
연구 개요
상태
상세 설명
Delirium is a syndrome characterized by failure of basic cognitive functions that affects approximately 20-50% of older surgical patients. Delirium during surgical recovery is associated with increased mortality, cognitive and functional decline, and prolonged hospitalization. In fact, 3-year survival rates for acutely hospitalized patients with delirium, and subsyndromal delirium, are both less than 50%. Older age is predictive of delirium after surgery, and with aging surgical populations, the incidence of postoperative delirium and related complications are likely to increase in the coming years.
Caffeine represents a novel, neurobiologically informed candidate intervention for reducing risk of early postoperative delirium. Caffeine promotes arousal via adenosine receptor antagonism and improves cognitive function concurrent with increased cortical cholinergic tone. Our preliminary data suggest that caffeine reduces risk of postanesthesia care unit (PACU) delirium in adult non-cardiac surgery patients by optimizing cortical dynamics for cognition. Caffeine also optimizes key neurocognitive processes that support information processing and may improve other, related aspects of clinical recovery, such as rebound headache in habitual caffeine users. The objective of this trial is to thus test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, the primary hypothesis is that caffeine will reduce the incidence of postoperative delirium. The secondary objectives are to (1) test whether caffeine positively impacts the quality of postoperative recovery via validated patient-reported measures and (2) identify neural correlates of delirium and Mild Cognitive Impairment via advanced electroencephalographic (EEG) analysis.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- Michigan Medicine
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adult (>/= 70 years old) undergoing non-cardiac, non-intracranial neurologic, non-major vascular surgery requiring general anesthesia with a planned admission for at least 48 hours.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Provision of signed and dated informed consent form.
Exclusion Criteria:
- Emergency surgery
- Outpatient surgery
- Severe cognitive impairment precluding the capacity for informed consent
- Seizure disorder history
- Intolerance or allergy to caffeine (based on subjective reporting or objective documentation)
- Weight >130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA)
- Enrollment in conflicting research study
- Patients in acute liver failure
- Acute kidney injury preoperatively
- Diagnosis of pheochromocytoma
- Active carcinoid syndrome
- Severe audiovisual impairment
- Non-English speaking
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Control
Prepared intravenous piggyback solution of 5 percent dextrose water at multiple postoperative time points over a 30-minute infusion period. |
Dextrose 5% in water |
|
실험적: Low-dose Caffeine
Prepared intravenous low-dose caffeine citrate (1.5 mg/kg) at multiple postoperative time points over a 30-minute infusion period. |
Low-dose caffeine citrate (1.5 mg/kg) High-dose Caffeine citrate (3 mg/kg) |
|
실험적: High-dose Caffeine
Prepared intravenous high-dose caffeine citrate (3 mg/kg) at multiple postoperative time points over a 30-minute infusion period. |
Low-dose caffeine citrate (1.5 mg/kg) High-dose Caffeine citrate (3 mg/kg) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Delirium
기간: Day of surgery through afternoon of postoperative day three
|
Any positive delirium screen (yes/no) as determined by the long-form Confusion Assessment Method (CAM), and supplemented by a validated daily chart review method. |
Day of surgery through afternoon of postoperative day three
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Delirium Severity
기간: Day of surgery through afternoon of postoperative day three
|
For all participants screened for delirium, the associated severity score will be recorded using the Confusion Assessment Method Long Form Severity Score (CAM-S) (n, 0-19, with higher number indicating more severe delirium) |
Day of surgery through afternoon of postoperative day three
|
|
Delirium Duration
기간: Day of surgery through afternoon of postoperative day three
|
The cumulative number of days (n) with a positive delirium screen will be calculated for all participants |
Day of surgery through afternoon of postoperative day three
|
|
Patient-Reported Quality of Recovery
기간: Preoperative baseline through postoperative day three afternoon
|
Assessed via the 15-item Quality of Recovery Score (n, 0-150, with higher number indicating better quality of recovery from the patient perspective) |
Preoperative baseline through postoperative day three afternoon
|
|
Sedation
기간: Preoperative baseline through postoperative day three afternoon
|
Any positive screen based on the Richmond Agitation Sedation Scale (RASS; n, -5 to +4). Scores from -5 to -2 will count as a positive screen for sedation. |
Preoperative baseline through postoperative day three afternoon
|
|
Agitation
기간: Preoperative baseline through postoperative day three afternoon
|
Any positive screen based on the Richmond Agitation Sedation Scale (RASS; n, -5 to +4). Scores from +2 to +4 will count as a positive screen for agitation |
Preoperative baseline through postoperative day three afternoon
|
|
Headache
기간: Preoperative baseline through postoperative day three afternoon
|
Headache severity will be assessed via 10-centimeter visual analog scale (0-100 mm, with higher score indicating more severe headache) |
Preoperative baseline through postoperative day three afternoon
|
|
Cumulative Opioid Consumption
기간: Day of surgery through postoperative day three afternoon
|
Postoperative opioid consumption, oral morphine equivalents (mg) |
Day of surgery through postoperative day three afternoon
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Anesthetic Emergence
기간: Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes
|
Time (minutes) from surgical closure to extubation |
Duration of time from surgical dressing completion to anesthetic emergence (min); generally expected to be between 10 and 60 minutes
|
|
Pulmonary Complications
기간: From extubation until end of postanesthesia care unit stay
|
Composite outcome (yes/no) of any of the following: airway adjunct use, unplanned continuous positive airway pressure device, unplanned humidified high-flow oxygen, need for bag-mask ventilation, or reintubation |
From extubation until end of postanesthesia care unit stay
|
|
Hospital Length of Stay
기간: Morning of surgery until day of hospital discharge, up to 30 days
|
Total number of days (n) spent in the hospital, up to 30 days |
Morning of surgery until day of hospital discharge, up to 30 days
|
|
Discharge Disposition
기간: Day of hospital discharge, up to 30 days
|
Proportion of patients in each group (%) discharged somewhere other than home (e.g., Long-Term Care Facility), up to 30 days |
Day of hospital discharge, up to 30 days
|
|
30-Day Cognitive Function
기간: 30 days after hospital discharge
|
Cognitive function score based on the Montreal Cognitive Assessment (n, 0-30, with higher scores reflecting higher cognitive function) |
30 days after hospital discharge
|
|
30-Day Physical Function
기간: 30 days after hospital discharge
|
Physical function score based on the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 10a score (n, 10-50, with higher score indicating better physical function) |
30 days after hospital discharge
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Phillip Vlisides, MD, Assistant Professor of Anesthesiology
간행물 및 유용한 링크
일반 간행물
- Vlisides PE, Li D, McKinney A, Brooks J, Leis AM, Mentz G, Tsodikov A, Zierau M, Ragheb J, Clauw DJ, Avidan MS, Vanini G, Mashour GA. The Effects of Intraoperative Caffeine on Postoperative Opioid Consumption and Related Outcomes After Laparoscopic Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Jul 1;133(1):233-242. doi: 10.1213/ANE.0000000000005532.
- Kim H, McKinney A, Brooks J, Mashour GA, Lee U, Vlisides PE. Delirium, Caffeine, and Perioperative Cortical Dynamics. Front Hum Neurosci. 2021 Dec 20;15:744054. doi: 10.3389/fnhum.2021.744054. eCollection 2021.
- Vlisides PE, Ragheb J, McKinney A, Mentz G, Runstadler N, Martinez S, Jewell E, Lee U, Vanini G, Schmitt EM, Inouye SK, Mashour GA. Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial. BMJ Open. 2023 May 15;13(5):e073945. doi: 10.1136/bmjopen-2023-073945.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- HUM00218290
- R01AG075005 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Clinical and electroencephalographic data will be preserved and made available for sharing. Data will be saved in various formats, such as comma-separated values (CSV), open document format (ODF), and European Data Format (EDF) for waveform data. Software programs designed to accommodate electroencephalographic waveform data (e.g., MATLAB) will be required for data access and analysis. Specific software and coding recommendations can be made available upon data sharing request.
Any data not permitted to be shared, as specified in written informed consent documents, will be withheld. Likewise, no data will be shared that may compromise the safety or privacy of participants, and no data will be shared that would violate local, state, or federal laws or policies (including the Health Insurance Portability and Accountability Act). All data will be de-identified.
IPD 공유 기간
Scientific data will be made available after primary trial manuscripts (for both clinical and electroencephalographic data) are accepted for publication. Data will be made available for as long as possible in compliance with National Institutes of Health and University of Michigan policies.
IPD 공유 액세스 기준
Data will be shared upon execution of Data Use Agreements in compliance with University of Michigan policies and procedures. Interested researchers will need to contact the study PI (Dr. Vlisides) for obtaining data via Data Use Agreement. All data will be shared upon reasonable request after primary trial manuscripts are published.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .