Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
- Conditions
- Stroke
- Interventions
- Drug: Osmotic drugs
- Registration Number
- NCT05914272
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2592
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description control group Osmotic drugs Patient has not used osmotic drugs within 72 hours of admission. trement group Osmotic drugs Patient has used osmotic drugs within 72 hours of admission.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Trial Locations
- Locations (19)
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Hainan Traditional Chinese Medicine Hospital
🇨🇳Haikou, Hainan, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Ganzhou City People's Hospital
🇨🇳Ganzhou, Jiangxi, China
Second Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The Fourth Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Hainan People's Hospital
🇨🇳Haikou, Hainan, China
Dongguan donghua hospital
🇨🇳Dongguan, Guangdong, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Huadu District People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
🇨🇳Huizhou, Guangdong, China
Heyuan people's Hospital
🇨🇳Heyuan, Guangdong, China
Haikou People's Hospital
🇨🇳Haikou, Hainan, China
The Second Hospital University of South China
🇨🇳Hengyang, Hunan, China
Sinopharm North Hospital
🇨🇳Baotou, Inner Mongolia, China
Yueyang People's Hospital
🇨🇳Yueyang, Hunan, China
Kashgar 1st People's Hospital
🇨🇳Kashgar, Xinjiang, China