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

June 20, 2023 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2592

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
        • Contact:
          • Shenggen Chen, M.D.
          • Phone Number: 13459480275
    • Guangdong
      • Dongguan, Guangdong, China
        • Dongguan People's Hospital
      • Dongguan, Guangdong, China
        • Dongguan Donghua Hospital
        • Contact:
          • Lingyu Sun, M.D.
          • Phone Number: 13829203368
      • Guangzhou, Guangdong, China
        • Guangdong Provincial Hospital of Traditional Chinese Medicine
        • Contact:
          • Lixin Wang, M.D.
          • Phone Number: 13922793886
      • Guangzhou, Guangdong, China
        • Huadu District People's Hospital of Guangzhou
        • Contact:
          • Guangning Li, M.D.
          • Phone Number: 13926239656
      • Guangzhou, Guangdong, China
        • The Fourth Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Wangchi Luo, M.D.
          • Phone Number: 13710895142
      • Heyuan, Guangdong, China
        • Heyuan People's Hospital
        • Contact:
          • Minzhen Zhu, M.D.
          • Phone Number: 15007622318
      • Huizhou, Guangdong, China
        • Huizhou Municipal Central Hospital
        • Contact:
          • Lizhi Wang, M.D.
          • Phone Number: 13802872076
    • Hainan
      • Haikou, Hainan, China
        • Haikou People's Hospital
        • Contact:
          • Guoshuai Yang, M.D.
          • Phone Number: 13876006248
      • Haikou, Hainan, China
        • Hainan Traditional Chinese Medicine Hospital
        • Contact:
          • Yong Gu, M.D.
          • Phone Number: 15521280288
      • Haikou, Hainan, China
        • Hainan People's Hospital
        • Contact:
          • Fan Zhang, M.D.
          • Phone Number: 17389897580
    • Hunan
      • Changsha, Hunan, China
        • The First Hospital of Changsha
        • Contact:
          • Xu Peng, M.D.
          • Phone Number: 15802507292
      • Hengyang, Hunan, China
        • The Second Hospital University of South China
        • Contact:
          • Yanhong Hu, M.D.
          • Phone Number: 13265004191
      • Yueyang, Hunan, China
        • Yueyang People's Hospital
        • Contact:
          • Yuan Zhou
          • Phone Number: 15107309796
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Sinopharm North Hospital
        • Contact:
          • Lifei Xing, M.D
          • Phone Number: 15354919958
      • Hohhot, Inner Mongolia, China
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Lihua Sun, M.D.
          • Phone Number: 18686292585
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Ganzhou City People's Hospital
        • Contact:
          • Zhaohui Lai, M.D.
          • Phone Number: 13879729792
    • Xinjiang
      • Kashgar, Xinjiang, China
        • Kashgar 1st People's Hospital
        • Contact:
          • Qingbo Lu, M.D.
          • Phone Number: 13201186636
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Second Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Saijun Zhou, M.D.
          • Phone Number: 13857746659

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days after onset
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
one year after onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
90 days after onset
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
90 days after onset
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
1 year after onset
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
30 days after onset
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
1 year after onset
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Time Frame: Up to 3 days
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Up to 3 days
Incidence of need for decompressive hemicraniectomy
Time Frame: up to 24 hours
Incidence of need for decompressive hemicraniectomy after onset
up to 24 hours
The actual incidence of decompressive hemicraniectomy
Time Frame: up to 24 hours
The actual incidence of decompressive hemicraniectomy after onset
up to 24 hours
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
up to 24 hours
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
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Second Affiliated Hospital of Guangxi Medical University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Fujian Medical University Union Hospital
Second Affiliated Hospital of Wenzhou Medical University
Dongguan People's Hospital
Huizhou Municipal Central Hospital
The Affiliated Hospital of Inner Mongolia Medical University
Hainan People's Hospital
Huadu District People's Hospital of Guangzhou
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Kashgar 1st People's Hospital
The Second Hospital University of South China
Haikou People's Hospital
Ganzhou City People's Hospital
The Fourth Affiliated Hospital of Guangzhou Medical University
Sinopharm North Hospital
Hainan Traditional Chinese Medicine Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suyue Pan, Department of Neurology, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2023-039

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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