Osmotic drugs
DrugPatients had used osmotic drugs within 72 hours of admission.
NCT Number: NCT05914272
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients had used osmotic drugs within 72 hours of admission.
Time frame: 90 days after onset
Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: one year after onset
Incidence of acute renal impairment after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 3 days
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Time frame: up to 24 hours
Incidence of need for decompressive hemicraniectomy after onset
Time frame: up to 24 hours
The actual incidence of decompressive hemicraniectomy after onset
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07735676
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07735702
Brain Diseases, Cardiovascular Diseases
Dhaka, Bangladesh
View Trial DetailsNCT07740668
Brain Diseases, Cardiovascular Diseases
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07739264
Brain Diseases, Brain Injuries
Dhaka, Bangladesh
View Trial Details