StrokeNCT05914272
Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
An observational study of Stroke, run by Nanfang Hospital, Southern Medical University at 19 sites in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Osmotic drugs
- How many people
- 2,592 participants
- Where
- 19 sitesChina
- Study dates
- 1 Jul 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
Sinopharm North Hospital
Baotou, Inner Mongolia
Lifei Xing, M.D, 15354919958
The First Hospital of Changsha
Changsha, Hunan
Xu Peng, M.D., 15802507292
Dongguan donghua hospital
Dongguan, Guangdong
Lingyu Sun, M.D., 13829203368
Dongguan People's Hospital
Dongguan, Guangdong
Fujian Medical University Union Hospital
Fuzhou, Fujian
Shenggen Chen, M.D., 13459480275
Ganzhou City People's Hospital
Ganzhou, Jiangxi
Zhaohui Lai, M.D., 13879729792
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong
Lixin Wang, M.D., 13922793886
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong
Guangning Li, M.D., 13926239656
The Fourth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Wangchi Luo, M.D., 13710895142
Haikou People's Hospital
Haikou, Hainan
Guoshuai Yang, M.D., 13876006248
Hainan People's Hospital
Haikou, Hainan
Fan Zhang, M.D., 17389897580
Hainan Traditional Chinese Medicine Hospital
Haikou, Hainan
Yong Gu, M.D., 15521280288
The Second Hospital University of South China
Hengyang, Hunan
Yanhong Hu, M.D., 13265004191
Heyuan people's Hospital
Heyuan, Guangdong
Minzhen Zhu, M.D., 15007622318
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Lihua Sun, M.D., 18686292585
Huizhou Municipal Central Hospital
Huizhou, Guangdong
Lizhi Wang, M.D., 13802872076
Kashgar 1st People's Hospital
Kashgar, Xinjiang
Qingbo Lu, M.D., 13201186636
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Saijun Zhou, M.D., 13857746659
Yueyang People's Hospital
Yueyang, Hunan
Yuan Zhou, 15107309796
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Osmotic drugs
- Keywords
- Stroke, large hemispheric infarction, osmotic drugs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmotic drugsDrug
Patients had used osmotic drugs within 72 hours of admission.
| Study group | Role | What they receive |
|---|---|---|
| trement group | Patient has used osmotic drugs within 72 hours of admission. Receives: Drug: Osmotic drugs | |
| control group | Patient has not used osmotic drugs within 72 hours of admission. Receives: Drug: Osmotic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
Mortality within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 90 days after onset
Incidence of acute renal impairment
Incidence of acute renal impairment after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: one year after onset
Secondary outcomes (10)
90-day mRS
Modified Rankin Scale score within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 90 days after onset
90-day mRS score change
Modified Rankin Scale score change within 90 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 90 days after onset
one year mRS
Modified Rankin Scale score within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 1 year after onset
Incidence of early neurological deterioration
Incidence of early neurological deterioration within 30 days after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 30 days after onset
Incidence of malignant cerebral edema
Incidence of malignant cerebral edema within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: 1 year after onset
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Measured: Up to 3 days
Incidence of need for decompressive hemicraniectomy
Incidence of need for decompressive hemicraniectomy after onset
Measured: up to 24 hours
The actual incidence of decompressive hemicraniectomy
The actual incidence of decompressive hemicraniectomy after onset
Measured: up to 24 hours
Incidence of Symptomatic intracranial hemorrhage
Incidence of Symptomatic intracranial hemorrhage within 1 year after onset in patients with large hemispheric infarction who were eligible for inclusion criteria
Measured: up to 24 hours
Incidence of drug-related adverse events
Incidence of adverse events due to drugs within 1 year after the onset of large hemispheric infarction in patients who met the inclusion criteria
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- 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, 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
- Responsible party
- Sponsor
- Investigators
- Suyue Pan, Principal investigator, Department of Neurology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914272
- Sponsor's protocol ID
- NFEC-2023-039
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction: a Prospective, Multicenter, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05914272
- Acronym / sponsor ID
- NFEC-2023-039
- Conditions
- Stroke
- Keywords
- Stroke, large hemispheric infarction, osmotic drugs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,592 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- 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, 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
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trement group | – | Drug: Osmotic drugsPatient has used osmotic drugs within 72 hours of admission. |
| control group | – | Drug: Osmotic drugsPatient has not used osmotic drugs within 72 hours of admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osmotic drugsPatients had used osmotic drugs within 72 hours of admission. | Drug | control group, trement group |
Primary outcome
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
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
10 secondary outcomes
90-day mRS
Time frame: 90 days after onset
90-day mRS score change
Time frame: 90 days after onset
one year mRS
Time frame: 1 year after onset
Incidence of early neurological deterioration
Time frame: 30 days after onset
Incidence of malignant cerebral edema
Time frame: 1 year after onset
Clinical correction rate of brain herniation before decompressive hemicraniectomy
Time frame: Up to 3 days
Incidence of need for decompressive hemicraniectomy
Time frame: up to 24 hours
The actual incidence of decompressive hemicraniectomy
Time frame: up to 24 hours
Incidence of Symptomatic intracranial hemorrhage
Time frame: up to 24 hours
Incidence of drug-related adverse events
Time frame: up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suyue Pan principal investigator
Department of Neurology, Nanfang Hospital, Southern Medical University
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Nanfang Hospital, Southern Medical University at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suyue Pan, MD PH.D. (13556184981, pansuyue@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day mortality (time frame: 90 days after onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.