Pharmacological Management of Delirium (PMD)
연구 개요
상태
상세 설명
In 2005, approximately 2.7 million Americans aged 65 and older spent at least one day in the intensive care unit (ICU), costing Medicare an estimated $27.5 billion. It is estimated that while hospitalized, up to 80% of these older ICU patients had delirium, an acute brain failure that is an independent predictor of morbidity and mortality which often goes unrecognized. Older adults with delirium are more prone to falls, injuries, pressure ulcers and restraints, complications which may also contribute to prolonged ICU and hospital length of stay, higher mortality rates, poorer functional status, limited rehabilitation, increased institutionalization, and higher health care costs. The literature supports treatment with a combination of a reduction in the use of benzodiazepines and anticholinergics and the use of low-dose neuroleptics such as haloperidol. However, there have been no randomized controlled trials evaluating the efficacy of this approach on reducing delirium severity, duration, and complications.
Building upon the e-CHAMP study, ("Enhancing Care for Hospitalized Older Adults With Memory Problems;" see NCT00182832), a recently completed quality improvement project tested the effectiveness of cognitive screening coupled with computerized decision support in reducing delirium and other hospital-related complications among 424 older adults hospitalized on the medical wards, which found that many of the older adults entering the study had already experienced delirium in the ICU prior to their transfer to the wards. This study will test a pharmacologic intervention that allows a more targeted approach to the care of older adults with delirium while still recognizing the clinicians' role in controlling symptoms and providing intensive care.
The hypothesis is that patients in the intervention arm as compared to usual care will have:
- reduced delirium severity, as measured by the Delirium Rating Scale (DRS-R-98), at one week following randomization or hospital discharge
- fewer hospital days with delirium or coma as determined by the Confusion Assessment Method in the ICU (CAM-ICU)
- shorter hospital lengths of stay
- lower ICU, hospital, and 30-day mortality
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Indiana
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Indianapolis, Indiana, 미국, 46202
- Methodist Hospital
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Indianapolis, Indiana, 미국, 46202
- University Hospital
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Indianapolis, Indiana, 미국, 46202
- Eskenazi Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18 years of age or older
- Hospitalized on an ICU ward
- Delirium based on the RASS and the CAM-ICU assessments at any day during ICU stay
- English speaking
Exclusion Criteria:
- Admitted directly to a regular non-ICU ward
- Previously enrolled in the study
- Not eligible for delirium assessment as determined by RASS scores
- Prior history of severe mental illness
- Alcohol-related delirium
- Pregnant or nursing
- Have had an aphasic stroke
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 |
|---|---|
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실험적: Haloperidol Eligible Intervention
0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines
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Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug. Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital
다른 이름들:
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활성 비교기: Haloperidol Eligible Usual Care
Usual care
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May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
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실험적: Haldol-Ineligible Arm
Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures. Patients are randomized and will still receive: reduced exposure to anticholinergics, reduced exposure to benzodiazepines |
Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug. Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol
Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation
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활성 비교기: Haldol Ineligible Usual Care
Usual Care
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May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Days Free of Delirium and Coma
기간: Admission through day 8 of stay
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Admission through day 8 of stay
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2차 결과 측정
결과 측정 |
기간 |
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Hospital Length of Stay Post Randomization
기간: Participants were followed for the duration of hospital stay, an average of 11 days
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Participants were followed for the duration of hospital stay, an average of 11 days
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Mortality
기간: ICU, in-hospital, 30-days post hospitalization
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ICU, in-hospital, 30-days post hospitalization
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공동 작업자 및 조사자
수사관
- 수석 연구원: Malaz Boustani, MD, Indiana University School of Medicine
간행물 및 유용한 링크
일반 간행물
- Ortiz D, Lindroth HL, Braly T, Perkins AJ, Mohanty S, Meagher AD, Khan SH, Boustani MA, Khan BA. Delirium severity does not differ between medical and surgical intensive care units after adjusting for medication use. Sci Rep. 2022 Aug 24;12(1):14447. doi: 10.1038/s41598-022-18429-9.
- Lindroth H, Khan BA, Carpenter JS, Gao S, Perkins AJ, Khan SH, Wang S, Jones RN, Boustani MA. Delirium Severity Trajectories and Outcomes in ICU Patients. Defining a Dynamic Symptom Phenotype. Ann Am Thorac Soc. 2020 Sep;17(9):1094-1103. doi: 10.1513/AnnalsATS.201910-764OC.
- Khan BA, Perkins AJ, Campbell NL, Gao S, Farber MO, Wang S, Khan SH, Zarzaur BL, Boustani MA. Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial. J Am Geriatr Soc. 2019 May;67(5):1057-1065. doi: 10.1111/jgs.15781. Epub 2019 Jan 25.
- Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, Abernathy G, Buckley J, Sing R, Tricker J, Zawahiri M, Boustani MA. Improving delirium care in the intensive care unit: the design of a pragmatic study. Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
섬망 상태에 대한 임상 시험
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Bozok University모병수술 후 합병증 | 소아 환자 | 수술 전 불안 (Ameliyat Öncesi Anksiyete) | Emergence Delirium (Derlenme Deliryumu)터키 (Türkiye)