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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of osmotic drugs, like mannitol and hypertonic saline, to see if they can improve outcomes for patients who have experienced a large hemispheric infarction, a serious type of stroke. These drugs are designed to help reduce swelling in the brain, which can happen after a stroke. The goal is to gather more information about how effective these medications are in improving patients' health 90 days or more after the stroke, especially for those who may not be able to receive more invasive treatments like surgery.

To be eligible for this study, participants need to be at least 18 years old and within 72 hours of their stroke onset. They must also meet specific criteria for having a severe stroke, as determined by brain scans. However, individuals who are pregnant, have certain serious health issues, or have had previous strokes with significant disabilities may not be able to participate. If selected, participants can expect to receive treatment with osmotic drugs and will be monitored to see how their condition develops over time. This study aims to provide valuable insights that could help doctors make better treatment decisions for stroke patients in the future.

Gender

ALL

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