REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH. (READY-ICH)
2026년 7월 5일 업데이트: Hong Yang, The Third Affiliated Hospital of Southern Medical University
Efficacy and Safety of an Early Intensive Blood Pressure-Lowering Strategy Using Remifentanil and Dexmedetomidine in Patients With Spontaneous Intracerebral Hemorrhage: A Multicenter, Prospective, Superiority, Randomized Controlled Trial
Intracerebral hemorrhage (ICH) remains the most devastating subtype of stroke, with a case fatality rate of approximately 40% at one months post-onset, imposing a particularly heavy medical and economic burden on low- and middle-income countries.
Studies have shown that poor prognosis in ICH patients is associated with acute blood pressure elevation and hematoma expansion after onset.
Blood pressure control during the acute phase is considered a potentially key therapeutic strategy for improving outcomes in ICH patients; however, no clinical study has yet demonstrated a clear advantage of any specific antihypertensive agent or combination.
Previous researchers have confirmed that the combined use of remifentanil and dexmedetomidine, while providing effective analgesia, sedation, and anti-sympathetic effects, could reduce dramatic fluctuations in blood pressure and heart rate, thereby facilitating more stable blood pressure reduction and potentially further improving functional outcomes in ICH patients.
The investigators plan to conduct a multicenter, prospective, randomized controlled, superiority clinical trial within mainland China to evaluate the efficacy and safety of an early intensive blood pressure-lowering strategy using remifentanil combined with dexmedetomidine for improving functional prognosis in acute ICH patients.
This study aims to provide evidence-based medical support for the use of remifentanil combined with dexmedetomidine in early intensive blood pressure-lowering in patients with ICH, to enrich the available options for early intensive blood pressure-lowering strategies, to improve the adverse prognosis of patients.
연구 개요
상세 설명
Spontaneous intracerebral hemorrhage refers to non-traumatic bleeding within the brain parenchyma caused by the rupture of large or small arteries, veins, or capillaries, which may secondarily extend into the ventricles or subarachnoid space. As one of the most devastating subtypes of stroke, intracerebral hemorrhage has a 30-day mortality rate of approximately 40%, with only 12-39% of patients regaining functional independence. Studies have shown that poor outcomes in intracerebral hemorrhage patients are closely associated with acute elevated blood pressure and hematoma expansion after onset, highlighting the urgent need to optimize clinical interventions. Therefore, understanding the pathophysiological mechanisms of acute blood pressure changes in intracerebral hemorrhage and refining early intensive antihypertensive strategies are of great clinical importance for improving patient outcomes. Previous researchers have demonstrated that a remifentanil and dexmedetomidine-based antihypertensive strategy enables rapid and stable blood pressure reduction. The investigators now intend to further investigate the efficacy and safety of this regimen compared to guideline-based standard treatment in improving patient outcomes.
This multi-center, prospective, open-label, randomized controlled, superiority clinical trial will be planned to be conducted in mainland China. It will primarily enroll patients with acute intracerebral hemorrhage who present within 6 hours of symptom onset and have an initial systolic blood pressure of 150 mmHg or higher. Patients will be excluded if they have contraindications to urgent intensive blood pressure-lowering therapy, if the hemorrhage is secondary to other etiologies, or if they have a high risk of death within 24 hours. Based on sample size calculation, a total of 1,116 patients with acute intracerebral hemorrhage will be enrolled and allocated in a 1:1 ratio to either the intervention group or the control group through randomization. Participants assigned to the control group will receive conventional treatment according to the "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage" published by the American Heart Association and the American Stroke Association. Participants assigned to the intervention group will receive early intensive blood pressure-lowering therapy with remifentanil combined with dexmedetomidine, in addition to the guideline-based standard treatment. Specifically, remifentanil and dexmedetomidine will be administered as soon as possible within 30 minutes after enrollment. The primary outcome measure of this study is the modified Rankin Scale score at 90 days after treatment. Secondary outcome measures include blood pressure and blood glucose levels during the treatment period, the incidence of hematoma expansion, and the length of stay in the intensive care unit, among others. The results of this study are expected to fill the evidence gap regarding specific antihypertensive combinations in improving functional outcomes, and to provide high-quality evidence for future guideline updates.
연구 유형
중재적
등록 (추정된)
1116
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Rui Dong, MM
- 전화번호: +86 -15622176026
- 이메일: dongrui_0419@163.com
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Age ≥ 18 years.
- Acute intracerebral hemorrhage confirmed by non-contrast head computed tomography.
- Symptom onset ≤ 6 h before randomization.
- At least two systolic blood pressure ≥ 150 mmHg separated by > 2 min prior to randomization.
- Admission to a monitored unit capable of active acute care (e.g., acute stroke unit, emergency department, or intensive care unit).
- Written informed consent provided by the patient or legally authorized representative.
Exclusion Criteria:
- Contraindication to intensive blood-pressure lowering (e.g., severe stenosis of carotid, vertebral, or cerebral arteries; Moyamoya disease; Takayasu arteritis; critical aortic stenosis).
- Clear evidence that the hemorrhage is secondary to a structural brain abnormality (arteriovenous malformation, aneurysm, tumor, trauma, infarct) or recent thrombolysis.
- Ischemic stroke within the preceding 30 days.
- Very high probability of death within 24 h based on clinical and/or radiologic criteria.
- Known advanced dementia or pre-stroke disability (pre- modified Rankin Scale score ≥ 3).
- Coagulopathy due to medication or hematologic disorder.
- Comorbid conditions that would interfere with outcome assessment or follow-up (e.g., active malignancy, end-stage organ failure).
- Known hypersensitivity to remifentanil or dexmedetomidine.
- Pregnancy or lactation.
- Concurrent participation in another investigational drug or device trial.
- Patient or legally authorized representative unwilling or unable to provide informed consent, or judged unlikely to comply with study procedures or follow-up.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Guideline-based standard care using remifentanil and dexmedetomidine
Based on the standard blood pressure treatment protocol from the 2022 American Heart Association/American Stroke Association "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage," the administration of remifentanil and dexmedetomidine will be initiated within 1 hour after randomization.
The treatment will be continued for 7 days, or until the patient is transferred out of the intensive care unit if this occurs before day 7.
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Participants will receive remifentanil and dexmedetomidine within 30 minutes after treatment initiation, and the treatment will be continued for 7 days or until discharge from the intensive care unit.
The starting dose of remifentanil is 0.025 μg/kg/min, which will be adjusted during infusion based on the patient's blood pressure and analgesic requirements.
For non-mechanically ventilated patients, the dose adjustment range is 0.025-0.05
μg/kg/min; for mechanically ventilated patients, the dose adjustment range is 0.025-0.15
μg/kg/min.
The starting dose of dexmedetomidine is 0.2 μg/kg/h, which will be adjusted during infusion based on the patient's blood pressure and sedation requirements, with a dose adjustment range of 0.2-0.7 μg/kg/h.
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활성 비교기: Guideline-based standard care
Management will follow the 2022 American Heart Association/American Stroke Association "Guidelines for the Management of Patients with Spontaneous Intracerebral Hemorrhage".
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Participants will receive conventional treatment in accordance with the "Guidelines for the Management of Spontaneous Intracerebral Hemorrhage" published by the American Heart Association and the American Stroke Association.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The modified Rankin Scale score at 90 days post-treatment
기간: 90 days post-treatment
|
The modified Rankin Scale score at 90 days post-treatment will be analyzed as an ordinal outcome (scores 0-6).
The modified Rankin Scale is a standardized global 7-level disability scale, where a score of 0 or 1 indicates a favorable outcome (no symptoms or no significant disability), scores 2-5 represent increasing levels of disability and dependency, and a score of 6 indicates death.
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90 days post-treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Poor Functional Outcome
기간: 90 days post-treatment
|
A modified Rankin Scale score of 3-6 at 90 days is defined as a poor outcome, including death and severe disability.
Death is defined as modified Rankin Scale 6, and severe disability is defined as modified Rankin Scale 3-5.
Death and severe disability will be combined and reported as a composite poor outcome measure, and will also be analyzed separately.
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90 days post-treatment
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Blood Pressure Management
기간: 24 hours, 3 days, and 7 days post-treatment
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(1) 1-hour blood pressure control rate: Defined as at least twice systolic blood pressure measurements <140 mmHg within the first hour after treatment initiation.
(2) Mean blood pressure values: The average blood pressure values within 24 hours, 3 days, and 7 days post-treatment will be calculated for each group using all available measurements.
(3) Blood pressure variability: Coefficient of Variation and Average Real Variability will be calculated based on all blood pressure measurements obtained within 24 hours, 3 days, and 7 days post-treatment.
(4) Use of antihypertensive agents: The need for antihypertensive medications within 24 hours, 3 days, and 7 days post-treatment will be recorded.
Intravenous and oral/enteral medications will be documented separately, including the number of agents used if applicable.
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24 hours, 3 days, and 7 days post-treatment
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Glycemic Control
기간: 24 hours, 3 days, and 7 days post-treatment
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(1) Mean blood glucose values: The average glucose values within 24 hours, 3 days, and 7 days post-treatment will be calculated for each group using all available measurements.
(2) Hypoglycemia rate: Hypoglycemia is defined as a blood glucose level <2.8 mmol/L in non-diabetic patients and <4.0 mmol/L in diabetic patients.
The actual glucose value at the time of hypoglycemia will also be recorded.
(3) Insulin use: The need for insulin and the total insulin dosage within 24 hours, 3 days, and 7 days post-treatment will be documented.
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24 hours, 3 days, and 7 days post-treatment
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National Institutes of Health Stroke Scale
기간: 7 days
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National Institutes of Health Stroke Scale at 7 days will be evaluated.
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7 days
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Glasgow Coma Scale
기간: 7 days
|
Glasgow Coma Scale at 7 days will be evaluated.
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7 days
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Hematoma Expansion
기간: 24 hours and 7 days
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Hematoma expansion is defined as an absolute increase in hematoma volume ≥12.5 mL or a relative increase >33% from baseline (V₁) to 24-hour of 7 days follow-up computed tomography (V₂), where V₁ is the baseline hematoma volume and V₂ is the volume at 24 hours and 7 days.
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24 hours and 7 days
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Quality of Life Assessment
기간: 90 days
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The EuroQol Five-Dimension Three-Level Questionnaire56 will be used to assess health-related quality of life at 90 days.
The EuroQol 5-dimension 3-level (EQ-5D-3L) patient-reported questionnaire covers 5 domains of health-related quality of life: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression.
Each domain has 3 graded levels of response: no problems, moderate, problems, or extreme problems.
Scores from these levels are combined to provide an overall health utility score that was calculated according to population norms in China.
A score of 1 represents perfect health, a score of 0 represents death, and negative scores represent health states considered to be worse than death.
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90 days
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Duration of Mechanical Ventilation
기간: 7 days
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For patients requiring mechanical ventilation, the start and end times of ventilation in the intensive care unit will be recorded, and the duration will be calculated in hours.
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7 days
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Intensive care unit Length of Stay
기간: 7 days
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The dates of intensive care unit admission and discharge will be recorded, and the length of stay will be calculated in days.
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7 days
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Hospitalization Status at 90 Days
기간: 90 days
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Whether the patient remains hospitalized at 90 days will be documented.
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90 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Hong Yang, MD, The Third Affiliated Hospital of Southern Medical University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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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 (추정된)
2026년 7월 31일
기본 완료 (추정된)
2028년 10월 1일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 28일
QC 기준을 충족하는 최초 제출
2026년 7월 5일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 5일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026SMU017
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
This study plans to make study protocol available to individuals or institutions in need after the completion of participant enrollment and data collation.
Such requests can be made by contacting the principal investigator.
IPD 공유 기간
It is expected to be made available in June 2029 and will remain accessible for a period of 5 years.
IPD 공유 액세스 기준
Contacte to principal investigator.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .
뇌내출혈에 대한 임상 시험
-
Assistance Publique Hopitaux De Marseille완전한파킨슨 병 | STN 심부 뇌 자극을 위한 포함 기준 포함 | Intracerebral Electrode Implantati에 대한 금기 사항 제시프랑스
Remifentanil and Dexmedetomidine에 대한 임상 시험
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University of OregonSpecial X Inc.완전한부모-자녀 관계 | 육아 | 아동 행동 | 발달 장애 | 개발 지연 | 발달 장애, 아동미국
-
University Hospitals Cleveland Medical Center알려지지 않은
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National University of Singapore완전한
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Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
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Academisch Medisch Centrum - Universiteit van Amsterdam...Angiogenesis Analytics아직 모집하지 않음
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Istituto per la Ricerca e l'Innovazione BiomedicaFondazione di Comunità di Messina onlus모병
-
GenSight Biologics모집하지 않고 적극적으로