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REmifentanil And Dexmedetomidine for EarlY Intensive Blood Pressure Lowering in ICH. (READY-ICH)

5. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1116

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Acute intracerebral hemorrhage confirmed by non-contrast head computed tomography.
  3. Symptom onset ≤ 6 h before randomization.
  4. At least two systolic blood pressure ≥ 150 mmHg separated by > 2 min prior to randomization.
  5. Admission to a monitored unit capable of active acute care (e.g., acute stroke unit, emergency department, or intensive care unit).
  6. Written informed consent provided by the patient or legally authorized representative.

Exclusion Criteria:

  1. Contraindication to intensive blood-pressure lowering (e.g., severe stenosis of carotid, vertebral, or cerebral arteries; Moyamoya disease; Takayasu arteritis; critical aortic stenosis).
  2. Clear evidence that the hemorrhage is secondary to a structural brain abnormality (arteriovenous malformation, aneurysm, tumor, trauma, infarct) or recent thrombolysis.
  3. Ischemic stroke within the preceding 30 days.
  4. Very high probability of death within 24 h based on clinical and/or radiologic criteria.
  5. Known advanced dementia or pre-stroke disability (pre- modified Rankin Scale score ≥ 3).
  6. Coagulopathy due to medication or hematologic disorder.
  7. Comorbid conditions that would interfere with outcome assessment or follow-up (e.g., active malignancy, end-stage organ failure).
  8. Known hypersensitivity to remifentanil or dexmedetomidine.
  9. Pregnancy or lactation.
  10. Concurrent participation in another investigational drug or device trial.
  11. Patient or legally authorized representative unwilling or unable to provide informed consent, or judged unlikely to comply with study procedures or follow-up.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Remifentanil and Dexmedetomidine
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.
Aktiver Komparator: 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".
Arzneimittel: Guideline standard care
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The modified Rankin Scale score at 90 days post-treatment
Zeitfenster: 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.
90 days post-treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Poor Functional Outcome
Zeitfenster: 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.
90 days post-treatment
Blood Pressure Management
Zeitfenster: 24 hours, 3 days, and 7 days post-treatment
(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.
24 hours, 3 days, and 7 days post-treatment
Glycemic Control
Zeitfenster: 24 hours, 3 days, and 7 days post-treatment
(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.
24 hours, 3 days, and 7 days post-treatment
National Institutes of Health Stroke Scale
Zeitfenster: 7 days
National Institutes of Health Stroke Scale at 7 days will be evaluated.
7 days
Glasgow Coma Scale
Zeitfenster: 7 days
Glasgow Coma Scale at 7 days will be evaluated.
7 days
Hematoma Expansion
Zeitfenster: 24 hours and 7 days
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.
24 hours and 7 days
Quality of Life Assessment
Zeitfenster: 90 days
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.
90 days
Duration of Mechanical Ventilation
Zeitfenster: 7 days
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.
7 days
Intensive care unit Length of Stay
Zeitfenster: 7 days
The dates of intensive care unit admission and discharge will be recorded, and the length of stay will be calculated in days.
7 days
Hospitalization Status at 90 Days
Zeitfenster: 90 days
Whether the patient remains hospitalized at 90 days will be documented.
90 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Third Affiliated Hospital of Southern Medical University

Mitarbeiter

Shenzhen People's Hospital

Ermittler

  • Hauptermittler: Hong Yang, MD, The Third Affiliated Hospital of Southern Medical University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

31. Juli 2026

Primärer Abschluss (Geschätzt)

1. Oktober 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

28. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026SMU017

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

It is expected to be made available in June 2029 and will remain accessible for a period of 5 years.

IPD-Sharing-Zugriffskriterien

Contacte to principal investigator.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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