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NOT YET RECRUITING
NCT05914272

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

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2592

Start Date

2023-07-01

Completion Date

2027-01-01

Last Updated

2023-06-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Osmotic drugs

Patients had used osmotic drugs within 72 hours of admission.

Locations (19)

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

Hainan Traditional Chinese Medicine Hospital

Haikou, Hainan, China

The First Hospital of Changsha

Changsha, Hunan, China

The Second Hospital University of South China

Hengyang, Hunan, China

Yueyang People's Hospital

Yueyang, Hunan, China

Sinopharm North Hospital

Baotou, Inner Mongolia, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

Kashgar 1st People's Hospital

Kashgar, Xinjiang, China

Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China