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

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ClinicalTrials.gov Identifier: NCT05914272
Recruitment Status : Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : June 22, 2023
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Nanfang Hospital, Southern Medical University

Study Description
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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
Stroke Drug: Osmotic drugs

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
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Study Type : Observational
Estimated Enrollment : 2592 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 90-day mortality [ Time Frame: 90 days after onset ]
    Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria

  2. Incidence of acute renal impairment [ 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


Secondary Outcome Measures :
  1. 90-day mRS [ 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

  2. 90-day mRS score change [ 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

  3. one year mRS [ 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

  4. Incidence of early neurological deterioration [ 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

  5. Incidence of malignant cerebral edema [ 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

  6. Clinical correction rate of brain herniation before decompressive hemicraniectomy [ Time Frame: Up to 3 days ]
    Clinical correction rate of brain herniation before decompressive hemicraniectomy

  7. Incidence of need for decompressive hemicraniectomy [ Time Frame: up to 24 hours ]
    Incidence of need for decompressive hemicraniectomy after onset

  8. The actual incidence of decompressive hemicraniectomy [ Time Frame: up to 24 hours ]
    The actual incidence of decompressive hemicraniectomy after onset

  9. Incidence of Symptomatic intracranial hemorrhage [ 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

  10. Incidence of drug-related adverse events [ 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute large hemispheric 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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05914272


Contacts
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Contact: Suyue Pan, MD PH.D. 13556184981 pansuyue@smu.edu.cn

Locations
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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
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Principal Investigator: Suyue Pan Department of Neurology, Nanfang Hospital, Southern Medical University
More Information
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Responsible Party: Nanfang Hospital, Southern Medical University
ClinicalTrials.gov Identifier: NCT05914272    
Other Study ID Numbers: NFEC-2023-039
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital, Southern Medical University:
Stroke
large hemispheric infarction
osmotic drugs
Additional relevant MeSH terms:
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Infarction
Ischemia
Pathologic Processes
Necrosis