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

Stroke Clinical Trial

Official title:

Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914272
• Other study ID #: NFEC-2023-039
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Suyue Pan, MD PH.D.
• Phone: 13556184981
• Email: pansuyue[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 2592
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Stroke

Intervention

Drug:
• Osmotic drugs
Patients had used osmotic drugs within 72 hours of admission.

Locations

Country	Name	City	State
China	Sinopharm North Hospital	Baotou	Inner Mongolia
China	The First Hospital of Changsha	Changsha	Hunan
China	Dongguan donghua hospital	Dongguan	Guangdong
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Ganzhou City People's Hospital	Ganzhou	Jiangxi
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	Haikou People's Hospital	Haikou	Hainan
China	Hainan People's Hospital	Haikou	Hainan
China	Hainan Traditional Chinese Medicine Hospital	Haikou	Hainan
China	The Second Hospital University of South China	Hengyang	Hunan
China	Heyuan people's Hospital	Heyuan	Guangdong
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Kashgar 1st People's Hospital	Kashgar	Xinjiang
China	Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Yueyang People's Hospital	Yueyang	Hunan

Sponsors (18)

Lead Sponsor

Collaborator

Nanfang Hospital, Southern Medical University

Dongguan People's Hospital, Fujian Medical University Union Hospital, Ganzhou City People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Haikou People's Hospital, Hainan People's Hospital, Hainan Traditional Chinese Medicine Hospital, Huadu District People's Hospital of Guangzhou, Huizhou Municipal Central Hospital, Kashgar 1st People's Hospital, Second Affiliated Hospital of Guangxi Medical University, Second Affiliated Hospital of Wenzhou Medical University, Sinopharm North Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The Fourth Affiliated Hospital of Guangzhou Medical University, The Second Hospital University of South China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	90-day mRS	Modified Rankin Scale score within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	90 days after onset
Secondary	90-day mRS score change	Modified Rankin Scale score change within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	90 days after onset
Secondary	one year mRS	Modified Rankin Scale score within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	1 year after onset
Secondary	Incidence of early neurological deterioration	Incidence of early neurological deterioration within 30 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	30 days after onset
Secondary	Incidence of malignant cerebral edema	Incidence of malignant cerebral edema within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	1 year after onset
Secondary	Clinical correction rate of brain herniation before decompressive hemicraniectomy	Clinical correction rate of brain herniation before decompressive hemicraniectomy	Up to 3 days
Secondary	Incidence of need for decompressive hemicraniectomy	Incidence of need for decompressive hemicraniectomy after onset	up to 24 hours
Secondary	The actual incidence of decompressive hemicraniectomy	The actual incidence of decompressive hemicraniectomy after onset	up to 24 hours
Secondary	Incidence of Symptomatic intracranial hemorrhage	Incidence of Symptomatic intracranial hemorrhage within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria	up to 24 hours
Secondary	Incidence of drug-related adverse events	Incidence of adverse events due to drugs within 1 year after the onset of large hemispheric infarction in patients who met the inclusion criteria	up to 24 hours