Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction

Официальное название

Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study

Обзор

Stroke remains the second leading cause of death worldwide, with 2%-8% of these being large hemispheric infarction (LHI) with an occupying effect and the worst prognosis. Even with medical and surgical treatment, the mortality of LHI with cerebral edema is as high as 20% to 30%. Current guidelines recommend supportive supervision, osmotic drugs, and decompressive hemicraniectomy (DHC) for the treatment of LHI, but not all patients with LHI are suitable for DHC, and not all of them can afford the high cost of DHC. In the real-world, the use of osmotic drugs is more common than DHC. The guideline recommends using mannitol or hypertonic saline to reduce cerebral edema and tissue displacement in patients with cerebral edema. Mannitol is the most widely used and longest-standing osmotic drug, and since 1965, hypertonic saline has been used to treat intracranial hypertension. Most of the previous studies compare the efficacy of DHC over medical therapy or compare the efficacy of mannitol with hypertonic saline, but there is an absence of clinical data on whether osmotic drug therapy can improve the clinical prognosis of patients with large hemispheric infarction at 90 days or even longer. Therefore, the purpose of this study was to investigate the association between the osmotic drug and clinical outcomes in large hemispheric infarction, with the aim of informing clinical decisions.

Подробное описание

Diagnostic criteria for large hemispheric infarction (LHI): CT within 6 hours of onset showing hypointense areas \> 1/3 of the middle cerebral artery territory, or hypointense areas \> 50% of the middle cerebral artery territory within 6 hours to 72h of onset. LHI is strongly associated with severe cerebral edema, which can occur to varying degrees cerebral edema within hours or days of LHI. In recent years, endovascular treatment has significantly improved the revascularization of patients with large vessel occlusive cerebral infarction and reduced the incidence of malignant progression and mortality in patients with acute LHI, but many patients still suffer from malignant brain edema (MBE), which leads to the worsening of the disease.

Вмешательства

• Препарат Osmotic drugs
  Patients had used osmotic drugs within 72 hours of admission.

Первичные конечные точки

• 90-day mortality [Срок оценки: 90 days after onset]
• Incidence of acute renal impairment [Срок оценки: one year after onset]

Вторичные конечные точки (10)

• 90-day mRS [Срок оценки: 90 days after onset]
• 90-day mRS score change [Срок оценки: 90 days after onset]
• one year mRS [Срок оценки: 1 year after onset]
• Incidence of early neurological deterioration [Срок оценки: 30 days after onset]
• Incidence of malignant cerebral edema [Срок оценки: 1 year after onset]
• Clinical correction rate of brain herniation before decompressive hemicraniectomy [Срок оценки: Up to 3 days]
• Incidence of need for decompressive hemicraniectomy [Срок оценки: up to 24 hours]
• The actual incidence of decompressive hemicraniectomy [Срок оценки: up to 24 hours]
• Incidence of Symptomatic intracranial hemorrhage [Срок оценки: up to 24 hours]
• Incidence of drug-related adverse events [Срок оценки: up to 24 hours]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Within 72 hours of onset of the stroke
• Meets the diagnostic criteria for acute ischaemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"
• Meeting the diagnostic criteria for massive cerebral infarction in the "Guidelines for the Surgical Treatment of Massive Cerebral Infarction": CT within 6 hours of onset showing hypointense areas > 1/3 of the middle cerebral artery territory, or > 50% of the middle cerebral artery territory within 6 hours to 72 hours of onset;
• The patient consented and signed an informed consent form.

Критерии исключения

• Women who are pregnant or breastfeeding;
• in combination with other serious comorbidities resulting in a life expectancy of less than 3 months
• Those who are allergic or intolerant to osmotic drugs;
• Those who have participated in other interventional clinical studies (which affecting the observation of outcomes in this cohort);
• Those with a previous history of stroke and significant residual neurological disability (mRS ≥ 2 points)
• Those who, in the judgment of the investigator, are not suitable for participation in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 19 центров

• Fujian Medical University Union Hospital — Фучжоу
• Dongguan donghua hospital — Дунгуань
• Dongguan People's Hospital — Дунгуань
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
• Huadu District People's Hospital of Guangzhou — Гуанчжоу
• The Fourth Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Heyuan people's Hospital — Heyuan
• Huizhou Municipal Central Hospital — Huizhou
• … и ещё 11 центров

Идентификаторы

NCT: NCT05914272 · NFEC-2023-039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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