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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04196322
Other study ID # El Zaitoun Specialized Hospita
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2016
Est. completion date November 12, 2017

Study information

Verified date February 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 1. Full clinical history …age, sex, weight and medical history 2. GCS and motor deficit 3. Random blood glucose level at admission and 4-6 times daily during hospital stay 4. HbA1c on admission 5. Hemodynamic monitoring 6. Duration of hospital stay 7. Thirty day mortality 8. Other laboratory investigation to rule out other similar cause 9. 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


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date November 12, 2017
Est. primary completion date October 20, 2017
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
observational study
observational study

Locations

Country Name City State
Egypt Hanaa El Gendy Cairo Ain Shams University Specialized Hospital

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary GCS GCS was assessed for 30 days 30 days
Secondary 30 days mortality 30 days mortality 30 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06250608 - Evaluation of rSO2 Between Frontal Lesion Area and Normal Area of Brain by NIRSITX Using NIRS in Acute Ischemic Stroke Patients. N/A