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.
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.
Study Type
OBSERVATIONAL
Enrollment
2,592
Patients had used osmotic drugs within 72 hours of admission.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Dongguan donghua hospital
Dongguan, Guangdong, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Heyuan people's Hospital
Heyuan, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Haikou People's Hospital
Haikou, Hainan, China
Hainan People's Hospital
Haikou, Hainan, China
...and 9 more locations
90-day mortality
Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 90 days after onset
Incidence of acute renal impairment
Incidence of acute renal impairment after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: one year after onset
90-day mRS
Modified Rankin Scale score within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 90 days after onset
90-day mRS score change
Modified Rankin Scale score change within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 90 days after onset
one year mRS
Modified Rankin Scale score within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 1 year after onset
Incidence of early neurological deterioration
Incidence of early neurological deterioration within 30 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 30 days after onset
Incidence of malignant cerebral edema
Incidence of malignant cerebral edema within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 1 year after onset
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Time frame: Up to 3 days
Incidence of need for decompressive hemicraniectomy
Incidence of need for decompressive hemicraniectomy after onset
Time frame: up to 24 hours
The actual incidence of decompressive hemicraniectomy
The actual incidence of decompressive hemicraniectomy after onset
Time frame: up to 24 hours
Incidence of Symptomatic intracranial hemorrhage
Incidence of Symptomatic intracranial hemorrhage within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: up to 24 hours
Incidence of drug-related adverse events
Incidence of adverse events due to drugs within 1 year after the onset of large hemispheric infarction in patients who met the inclusion criteria
Time frame: up to 24 hours
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