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

NCT05914272 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2592

Last updated 2023-06-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Osmotic drugs

Patients had used osmotic drugs within 72 hours of admission.

Sponsors & Collaborators

  • The Second Hospital University of South China

    collaborator OTHER
  • The Affiliated Hospital of Inner Mongolia Medical University

    collaborator OTHER
  • Second Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Second Affiliated Hospital of Guangxi Medical University

    collaborator OTHER
  • Fujian Medical University Union Hospital

    collaborator OTHER
  • Huizhou Municipal Central Hospital

    collaborator OTHER
  • Haikou People's Hospital

    collaborator OTHER
  • Kashgar 1st People's Hospital

    collaborator OTHER
  • Ganzhou City People's Hospital

    collaborator OTHER
  • Guangzhou Medical University

    collaborator OTHER
  • Dongguan People's Hospital

    collaborator OTHER_GOV
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

    collaborator OTHER
  • Hainan Traditional Chinese Medicine Hospital

    collaborator UNKNOWN
  • Hainan People's Hospital

    collaborator OTHER
  • Sinopharm North Hospital

    collaborator UNKNOWN
  • Huadu District People's Hospital of Guangzhou

    collaborator OTHER
  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Suyue Pan · Department of Neurology, Nanfang Hospital, Southern Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05914272 on ClinicalTrials.gov