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

5 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

1116

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Comparatore attivo: 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".
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The modified Rankin Scale score at 90 days post-treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Poor Functional Outcome
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 7 days
National Institutes of Health Stroke Scale at 7 days will be evaluated.
7 days
Glasgow Coma Scale
Lasso di tempo: 7 days
Glasgow Coma Scale at 7 days will be evaluated.
7 days
Hematoma Expansion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 90 days
Whether the patient remains hospitalized at 90 days will be documented.
90 days

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Third Affiliated Hospital of Southern Medical University

Collaboratori

Shenzhen People's Hospital

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

31 luglio 2026

Completamento primario (Stimato)

1 ottobre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026SMU017

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

Contacte to principal investigator.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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