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

NCT ID: NCT05914272

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2592 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2027-01-01

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.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

trement group

Patient has used osmotic drugs within 72 hours of admission.

Osmotic drugs

Intervention Type: DRUG

Patients had used osmotic drugs within 72 hours of admission.

control group

Patient has not used osmotic drugs within 72 hours of admission.

Osmotic drugs

Intervention Type: DRUG

Patients had used osmotic drugs within 72 hours of admission.

Interventions

Osmotic drugs

Patients had used osmotic drugs within 72 hours of admission.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital University of South China

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role: collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role: collaborator

Haikou People's Hospital

OTHER

Sponsor Role: collaborator

Kashgar 1st People's Hospital

OTHER

Sponsor Role: collaborator

Ganzhou City People's Hospital

OTHER

Sponsor Role: collaborator

Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Hainan Traditional Chinese Medicine Hospital

UNKNOWN

Sponsor Role: collaborator

Hainan People's Hospital

OTHER

Sponsor Role: collaborator

Sinopharm North Hospital

UNKNOWN

Sponsor Role: collaborator

Huadu District People's Hospital of Guangzhou

OTHER

Sponsor Role: collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suyue Pan

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Nanfang Hospital, Southern Medical University

Locations

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

Countries

China

Central Contacts

Suyue Pan, MD PH.D.

Role: CONTACT

pansuyue@smu.edu.cn

13556184981

Facility Contacts

Shenggen Chen, M.D.

Role: primary

13459480275

Lingyu Sun, M.D.

Role: primary

13829203368

Lixin Wang, M.D.

Role: primary

13922793886

Guangning Li, M.D.

Role: primary

13926239656

Wangchi Luo, M.D.

Role: primary

13710895142

Minzhen Zhu, M.D.

Role: primary

15007622318

Lizhi Wang, M.D.

Role: primary

13802872076

Guoshuai Yang, M.D.

Role: primary

13876006248

Fan Zhang, M.D.

Role: primary

17389897580

Yong Gu, M.D.

Role: primary

15521280288

Xu Peng, M.D.

Role: primary

15802507292

Yanhong Hu, M.D.

Role: primary

13265004191

Yuan Zhou

Role: primary

15107309796

Lifei Xing, M.D

Role: primary

15354919958

Lihua Sun, M.D.

Role: primary

18686292585

Zhaohui Lai, M.D.

Role: primary

13879729792

Qingbo Lu, M.D.

Role: primary

13201186636

Saijun Zhou, M.D.

Role: primary

13857746659

Other Identifiers

NFEC-2023-039

Identifier Type: -

Identifier Source: org_study_id