- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04196322
Hyperglycemia as a Prognostic Factor In Acute Ischemic Stroke Patients
Background: Hyperglycemia is encountered in 20% to 40% of acute stroke patients, with or without a pre-morbid diagnosis of diabetes mellitus. Hyperglycemia is a risk factor for infarct expansion and poor outcome through the first 72 hours of onset in both diabetics and non-diabetics patients. This study was done to evaluate the glycemic status after acute ischemic stroke and assess its rule in influencing stroke outcome as regards the duration of hospital stay, motor deficit and mortality.
Methods: This retrospective study was conducted in Elzaiton specialized hospital from June 2016 to June 2017on 80 patients after approval of local medical ethical committee. Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were included and divided into two groups, controlled group (Random blood suger not more than 150 mg/dl) and uncontrolled group ( Random blood suger more than 150 mg/dl). All patients were evaluated for GCS as a primary outcome and for hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors,hospital stay and mortality as secondary outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients and Methods This study was prospective study conducted in Elzaiton specialized hospital and Ain Shams University from june2016 to June 2017on 80 patients after approval of local medical ethical committee
All patients was subjected to the following
- Full clinical history …age, sex, weight and medical history
- GCS and motor deficit
- Random blood glucose level at admission and 4-6 times daily during hospital stay
- HbA1c on admission
- Hemodynamic monitoring
- Duration of hospital stay
- Thirty day mortality
- Other laboratory investigation to rule out other similar cause
- Follow up hemorrhagic transformation Study tools: Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated.
On ICU admission the random blood sugar was recorded and categorized to less than 150mg/dl (accepted) and more than 150mg/dl(not controlled). Also serial Random blood sugar daily was recorded and categorized to accepted or good control if less than 150mg/dl and not controlled if more than 150mg/dl.
Patients were divided into 2 groups Patients with accepted random blood sugar at admission and controlled blood sugar during hospital stay.
Patients with increased random blood sugar at admission and poor blood sugar control during hospital stay.
These data were collected and patients were observed as regards duration of hospital stay,hemorrhagic transformation, hospital stay duration and 30-days mortality
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ain Shams University Specialized Hospital
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Cairo, Ain Shams University Specialized Hospital, Egypt
- Hanaa El Gendy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated.
At ICU admission the random blood sugar was recorded and categorized to less than 150mg/dl (accepted) and more than 150mg/dl(not controlled). Also serial Random blood sugar daily was recorded and categorized to accepted or good control if less than 150mg/dl and not controlled if more than 150mg/dl.
Patients were divided into 2 groups Patients with accepted random blood sugar at admission and controlled blood sugar during hospital stay (B) Patients with increased random blood sugar at admission and poor blood sugar control during hospital stay These data were collected and patients were observed as regards duration of hospital stay, motor deficit improvement or worsening using Rating scale for muscle strength
Description
Inclusion criteria
- Age: 40-70years
- Sex: Any sex
- Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were evaluated.
Exclusion criteria
- Subdural heamatoma, metabolic causes or transient ischemic attack
- Sub arachnoid heamorrage
- Heamorragic stroke
- Patients with major comorbidities at admission as end stage liver disease, end stage renal disease and malignant hypertension
- Patients with hyperglycemia at admission and controlled blood sugar during hospital stay
- Patients with DKA or hypoglycemia (RBS less than 70 mg dl)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Controlled
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observational study
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Uncontrolled
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observational study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GCS
Time Frame: 30 days
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GCS was assessed for 30 days
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 days mortality
Time Frame: 30 days
|
30 days mortality
|
30 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Hyperglycemia
- Stroke
- Ischemic Stroke
- Ischemia
- Cerebral Infarction
Other Study ID Numbers
- El Zaitoun Specialized Hospita
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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