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NCT Number: NCT05914272

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital, Fuzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Within 72 hours of onset of the stroke
  • Meets the diagnostic criteria for acute ischaemic stroke in the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018"
  • 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;
  • The patient consented and signed an informed consent form.

Exclusion criteria

  • Women who are pregnant or breastfeeding;
  • in combination with other serious comorbidities resulting in a life expectancy of less than 3 months
  • Those who are allergic or intolerant to osmotic drugs;
  • Those who have participated in other interventional clinical studies (which affecting the observation of outcomes in this cohort);
  • Those with a previous history of stroke and significant residual neurological disability (mRS ≥ 2 points)
  • Those who, in the judgment of the investigator, are not suitable for participation in this study

Treatment and study plan

Osmotic drugs

Drug

Patients had used osmotic drugs within 72 hours of admission.

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Suyue Pan, MD PH.D.

CONTACT

[email protected]

13556184981

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Dongguan People's Hospital
  • Fujian Medical University Union Hospital
  • Ganzhou City People's Hospital
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Guangzhou Medical University
  • 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 Second Hospital University of South China

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

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.

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