Clinical trial NCT05914272: Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
Official title: Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Keywords: Stroke
large hemispheric infarction
osmotic drugs
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: The Second Hospital University of South China
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Second Affiliated Hospital of Guangxi Medical University
name: Fujian Medical University Union Hospital
name: Huizhou Municipal Central Hospital
name: Haikou People's Hospital
name: Kashgar 1st People's Hospital
name: Ganzhou City People's Hospital
name: Guangzhou Medical University
name: Dongguan People's Hospital
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: Hainan Traditional Chinese Medicine Hospital
name: Hainan People's Hospital
name: Sinopharm North Hospital
name: Huadu District People's Hospital of Guangzhou
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2023-06-22
Enrollment: 2592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute large hemispheric 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Within 72 hours of onset of the stroke
3. Meets the diagnostic criteria for acute ischaemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"
4. 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;
5. The patient consented and signed an informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days after onset
measure: Incidence of acute renal impairment
timeFrame: one year after onset
Secondary outcomes:
measure: 90-day mRS
timeFrame: 90 days after onset
measure: 90-day mRS score change
timeFrame: 90 days after onset
measure: one year mRS
timeFrame: 1 year after onset
measure: Incidence of early neurological deterioration
timeFrame: 30 days after onset
measure: Incidence of malignant cerebral edema
timeFrame: 1 year after onset
measure: Clinical correction rate of brain herniation before decompressive hemicraniectomy
timeFrame: Up to 3 days
measure: Incidence of need for decompressive hemicraniectomy
timeFrame: up to 24 hours
measure: The actual incidence of decompressive hemicraniectomy
timeFrame: up to 24 hours
measure: Incidence of Symptomatic intracranial hemorrhage
timeFrame: up to 24 hours
measure: Incidence of drug-related adverse events
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Dongguan
country: China
facility: Dongguan donghua hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Huadu District People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Fourth Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Heyuan
country: China
facility: Heyuan people's Hospital
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Haikou
country: China
facility: Haikou People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan People's Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Traditional Chinese Medicine Hospital
state: Hainan
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Hengyang
country: China
facility: The Second Hospital University of South China
state: Hunan
city: Yueyang
country: China
facility: Yueyang People's Hospital
state: Hunan
city: Baotou
country: China
facility: Sinopharm North Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Ganzhou
country: China
facility: Ganzhou City People's Hospital
state: Jiangxi
city: Kashgar
country: China
facility: Kashgar 1st People's Hospital
state: Xinjiang
city: Wenzhou
country: China
facility: Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Department of Neurology, Nanfang Hospital, Southern Medical University
name: Suyue Pan
role: PRINCIPAL_INVESTIGATOR
References: