Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| trement group Patient has used osmotic drugs within 72 hours of admission. |
Drug: Osmotic drugs
Patients had used osmotic drugs within 72 hours of admission.
|
| control group Patient has not used osmotic drugs within 72 hours of admission. |
Drug: Osmotic drugs
Patients had used osmotic drugs within 72 hours of admission.
|
Outcome Measures
Primary Outcome Measures
- 90-day mortality [90 days after onset]
Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- Incidence of acute renal impairment [one year after onset]
Incidence of acute renal impairment after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Secondary Outcome Measures
- 90-day mRS [90 days after onset]
Modified Rankin Scale score within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- 90-day mRS score change [90 days after onset]
Modified Rankin Scale score change within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- one year mRS [1 year after onset]
Modified Rankin Scale score within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- Incidence of early neurological deterioration [30 days after onset]
Incidence of early neurological deterioration within 30 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- Incidence of malignant cerebral edema [1 year after onset]
Incidence of malignant cerebral edema within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- Clinical correction rate of brain herniation before decompressive hemicraniectomy [Up to 3 days]
Clinical correction rate of brain herniation before decompressive hemicraniectomy
- Incidence of need for decompressive hemicraniectomy [up to 24 hours]
Incidence of need for decompressive hemicraniectomy after onset
- The actual incidence of decompressive hemicraniectomy [up to 24 hours]
The actual incidence of decompressive hemicraniectomy after onset
- Incidence of Symptomatic intracranial hemorrhage [up to 24 hours]
Incidence of Symptomatic intracranial hemorrhage within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
- Incidence of drug-related adverse events [up to 24 hours]
Incidence of adverse events due to drugs within 1 year after the onset of large hemispheric infarction in patients who met the inclusion criteria
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Within 72 hours of onset of the stroke
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Meets the diagnostic criteria for acute ischaemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"
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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;
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The patient consented and signed an informed consent form.
Exclusion Criteria:
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Women who are pregnant or breastfeeding;
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in combination with other serious comorbidities resulting in a life expectancy of less than 3 months
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Those who are allergic or intolerant to osmotic drugs;
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Those who have participated in other interventional clinical studies (which affecting the observation of outcomes in this cohort);
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Those with a previous history of stroke and significant residual neurological disability (mRS ≥ 2 points)
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Those who, in the judgment of the investigator, are not suitable for participation in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fujian Medical University Union Hospital | Fuzhou | Fujian | China | |
| 2 | Dongguan donghua hospital | Dongguan | Guangdong | China | |
| 3 | Dongguan People's Hospital | Dongguan | Guangdong | China | |
| 4 | Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangzhou | Guangdong | China | |
| 5 | Huadu District People's Hospital of Guangzhou | Guangzhou | Guangdong | China | |
| 6 | The Fourth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | |
| 7 | Heyuan people's Hospital | Heyuan | Guangdong | China | |
| 8 | Huizhou Municipal Central Hospital | Huizhou | Guangdong | China | |
| 9 | Haikou People's Hospital | Haikou | Hainan | China | |
| 10 | Hainan People's Hospital | Haikou | Hainan | China | |
| 11 | Hainan Traditional Chinese Medicine Hospital | Haikou | Hainan | China | |
| 12 | The First Hospital of Changsha | Changsha | Hunan | China | |
| 13 | The Second Hospital University of South China | Hengyang | Hunan | China | |
| 14 | Yueyang People's Hospital | Yueyang | Hunan | China | |
| 15 | Sinopharm North Hospital | Baotou | Inner Mongolia | China | |
| 16 | The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China | |
| 17 | Ganzhou City People's Hospital | Ganzhou | Jiangxi | China | |
| 18 | Kashgar 1st People's Hospital | Kashgar | Xinjiang | China | |
| 19 | Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | China |
Sponsors and Collaborators
- Nanfang Hospital, Southern Medical University
- The Second Hospital University of South China
- The Affiliated Hospital of Inner Mongolia Medical University
- Second Affiliated Hospital of Wenzhou Medical University
- Second Affiliated Hospital of Guangxi Medical University
- Fujian Medical University Union Hospital
- Huizhou Municipal Central Hospital
- Haikou People's Hospital
- Kashgar 1st People's Hospital
- Ganzhou City People's Hospital
- The Fourth Affiliated Hospital of Guangzhou Medical University
- Dongguan People's Hospital
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Hainan Traditional Chinese Medicine Hospital
- Hainan People's Hospital
- Sinopharm North Hospital
- Huadu District People's Hospital of Guangzhou
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
- Principal Investigator: Suyue Pan, Department of Neurology, Nanfang Hospital, Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NFEC-2023-039