Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
1 other identifier
observational
2,592
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
June 22, 2023
June 1, 2023
3.5 years
April 26, 2023
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
90-day mortality
Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
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
one year after onset
Secondary Outcomes (10)
90-day mRS
90 days after onset
90-day mRS score change
90 days after onset
one year mRS
1 year after onset
Incidence of early neurological deterioration
30 days after onset
Incidence of malignant cerebral edema
1 year after onset
- +5 more secondary outcomes
Study Arms (2)
trement group
Patient has used osmotic drugs within 72 hours of admission.
control group
Patient has not used osmotic drugs within 72 hours of admission.
Interventions
Patients had used osmotic drugs within 72 hours of admission.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- The Second Hospital University of South Chinacollaborator
- The Affiliated Hospital of Inner Mongolia Medical Universitycollaborator
- Second Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Second Affiliated Hospital of Guangxi Medical Universitycollaborator
- Fujian Medical University Union Hospitalcollaborator
- Huizhou Municipal Central Hospitalcollaborator
- Haikou People's Hospitalcollaborator
- Kashgar 1st People's Hospitalcollaborator
- Ganzhou City People's Hospitalcollaborator
- Guangzhou Medical Universitycollaborator
- Dongguan People's Hospitalcollaborator
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicinecollaborator
- Hainan Traditional Chinese Medicine Hospitalcollaborator
- Hainan People's Hospitalcollaborator
- Sinopharm North Hospitalcollaborator
- Huadu District People's Hospital of Guangzhoucollaborator
- Guangdong Provincial Hospital of Traditional Chinese Medicinecollaborator
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suyue Pan
Department of Neurology, Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2023
First Posted
June 22, 2023
Study Start
July 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
June 22, 2023
Record last verified: 2023-06