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임상시험 NCT05267886 (DOREMI-2)은(는) 심인성 쇼크에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock (DOREMI-2) 4상 346 무작위 배정 이중 눈가림 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT05267886 (DOREMI-2)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 심인성 쇼크에 대해 진행되며, 4상 중재연구으로 현재 상태는 모집중입니다. 연구는 2022년 3월 5일에 시작되어 346명의 참여자를 모집하고 있습니다. Ottawa Heart Institute Research Corporation이(가) 진행하며, 2026년 12월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 4월 10일에 갱신되었습니다.
간단한 개요
The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications ...더 보기
상세한 설명
Cardiogenic shock (CS) is a state of inadequate end-organ perfusion due to cardiac dysfunction. Acute myocardial infarction (AMI) remains the most prevalent cause of CS, with mortality reaching upwards of 40% despite advances in emergent revascularization and accelerating use of mechanical circulatory support devices. International guidelines support the use of vasopressors and inotropes as a mainstay of medical ther...더 보기
공식 제목
CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
질환명
심인성 쇼크기타 연구 식별자
- DOREMI-2
- 20210386
NCT 번호
실제 연구 시작일
2022-03-05
최신 업데이트 게시
2025-04-10
예상 연구 완료일
2026-12
계획된 등록 인원
346
연구종류
중재연구
단계/상
4상
상태
모집중
키워드
cardiogenic
shock
inotrope
shock
inotrope
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군Inotrope Participants randomized to receive the inotrope will be initiated on inotrope therapy at starting doses and titrated according to standard clinical care. During reassessment, the treating physicians will make a decision about adjustment of the inotrope dose (increase, maintain or decrease) based on hemodynamics, end-organ perfusion, vasopressor support and clinical exam. Dobutamine doses will be 2.5, 5.0, 7.5, 10 and...더 보기 | Dobutamine Dobutamine administered according to its clinical dose stage for cardiogenic shock Milrinone Milrinone administered according to its clinical dose stage for cardiogenic shock |
위약 대조군Placebo Participants in the placebo arm will have an intravenous solution of 0.9% NaCl running at a standardized rate, comparable to the infusion rate of the inotrope arm. | 생리 식염수 Normal saline running at a standardized rate |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Primary composite outcome | The primary outcome will be a composite of:
1. All-cause mortality during the hospitalization
2. Measured within the first 12 hours of starting the study intervention, any of:
1. Sustained hypotension (mean arterial pressure ≤55mmHg) or sustained requirement of high dose vasopressors (norepinephrine \>0.2 mcg/kg/min or norepinephrine 0.2 mcg/kg/min plus any additional agent) with any escalation in dose from time of randomization, for \>/= 60 minutes
2. Lactate greater than 3.5 mmol/L at 6 hours or thereafter
3. Need for mechanical circulatory support device
4. Atrial or ventricular arrhythmia leading to emergent electrical cardioversion
5. Resuscitated cardiac arrest | Through duration of hospitalization, up to 12 weeks following admission |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
All-cause in-hospital mortality | Death resulting from any cause during hospitalization | Through duration of hospitalization, up to 12 weeks following admission |
Renal failure requiring new initiation of renal replacement therapy | Requiring new initiation of renal replacement therapy | Through duration of hospitalization, up to 12 weeks following admission |
Need for cardiac transplant or mechanical circulatory support | Identification of needing a cardiac transplant or mechanical circulatory support | Through duration of hospitalization, up to 12 weeks following admission |
Atrial or ventricular arrhythmia leading to emergent electrical cardioversion | Requiring emergent electrical cardioversion for atrial or ventricular arrhythmia | Through duration of hospitalization, up to 12 weeks following admission |
Resuscitated cardiac arrest | Cardiopulmonary arrest requiring chest compressions and/or defibrillation with successful return of spontaneous circulation (ROSC) | Through duration of hospitalization, up to 12 weeks following admission |
Non-fatal myocardial infarction | Non-fatal myocardial infarction | Through duration of hospitalization, up to 12 weeks following admission |
Stroke or transient ischemic attack | Defined as an episode of focal or global neurological deficit as diagnosed by a neurologist | Through duration of hospitalization, up to 12 weeks following admission |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Adult patients ≥ 18 years of age admitted to an intensive care unit
- SCAI class C or D cardiogenic shock
- Unwilling or unable to obtain informed consent by the participant or substitute decision maker
- Patients who are currently pregnant or breast-feeding
- Patients presenting with an out-of-hospital cardiac arrest (OHCA)
- Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization
- Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis
- Dynamic left ventricular outflow tract obstruction
Ottawa Heart Institute Research Corporation연구 대표 연락처
연락처: Rebecca Mathew, MD, 613-696-7406, [email protected]
연락처: Baylie Morgan, RN, 613-696-7000, [email protected]
3 2개국에 임상시험 장소
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States
Benjamin M Hibbert, MD, PhD, 연락처, [email protected]
Benjamin M Hibbert, MD, PhD, 책임연구자
Jacob C Jentzer, MD, 공동연구자
대상자모집전
Ontario
Hamilton Health Sciences, Hamilton, Ontario, L8L 2X2, Canada
Emilie Belley-Cote, MD, 연락처, 905-521-2100
Emilie Belley-Cote, MD, 책임연구자
Richard Whitlock, MD, 공동연구자
Craig Ainsworth, MD, 공동연구자
Faizan Amin, MD, 공동연구자
모집중
University of Ottawa Heart Institute, Ottawa, Ontario, K1Y4W7, Canada
Rebecca Mathew, MD, 연락처, 613-696-7406, [email protected]
Rebecca Mathew, MD, 책임연구자
Pietro Di Santo, MD, 공동연구자
모집중