Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
NCT05914272 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2592
Last updated 2023-06-22
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.
Conditions
Interventions
- DRUG
-
Osmotic drugs
Patients had used osmotic drugs within 72 hours of admission.
Sponsors & Collaborators
-
The Second Hospital University of South China
collaborator OTHER -
The Affiliated Hospital of Inner Mongolia Medical University
collaborator OTHER -
Second Affiliated Hospital of Wenzhou Medical University
collaborator OTHER -
Second Affiliated Hospital of Guangxi Medical University
collaborator OTHER -
Fujian Medical University Union Hospital
collaborator OTHER -
Huizhou Municipal Central Hospital
collaborator OTHER -
Haikou People's Hospital
collaborator OTHER -
Kashgar 1st People's Hospital
collaborator OTHER -
Ganzhou City People's Hospital
collaborator OTHER -
Guangzhou Medical University
collaborator OTHER -
Dongguan People's Hospital
collaborator OTHER_GOV -
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
collaborator OTHER -
Hainan Traditional Chinese Medicine Hospital
collaborator UNKNOWN -
Hainan People's Hospital
collaborator OTHER -
Sinopharm North Hospital
collaborator UNKNOWN -
Huadu District People's Hospital of Guangzhou
collaborator OTHER -
Guangdong Provincial Hospital of Traditional Chinese Medicine
collaborator OTHER -
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Suyue Pan · Department of Neurology, Nanfang Hospital, Southern Medical University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2027-01-01
- Completion
- 2027-01-01
Countries
- China
Study Locations
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