Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05914272 |
Recruitment Status :
Not yet recruiting
First Posted : June 22, 2023
Last Update Posted : June 22, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Stroke | Drug: Osmotic drugs |
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 |
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. |
- 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
- 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-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
- 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
- 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
- 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
- Clinical correction rate of brain herniation before decompressive hemicraniectomy [ Time Frame: Up to 3 days ]Clinical correction rate of brain herniation before decompressive hemicraniectomy
- Incidence of need for decompressive hemicraniectomy [ Time Frame: up to 24 hours ]Incidence of need for decompressive hemicraniectomy after onset
- The actual incidence of decompressive hemicraniectomy [ Time Frame: up to 24 hours ]The actual incidence of decompressive hemicraniectomy after onset
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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
Contact: Suyue Pan, MD PH.D. | 13556184981 | pansuyue@smu.edu.cn |
Principal Investigator: | Suyue Pan | Department of Neurology, Nanfang Hospital, Southern Medical University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke large hemispheric infarction osmotic drugs |
Infarction Ischemia Pathologic Processes Necrosis |