Stress Hyperglycemia and Acute Ischemic Stroke

Stress Hyperglycemia Clinical Trial

Official title:

Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408768
• Other study ID #: El Zaiton Specialized Hospital
• Status: Completed
• Start date: May 17, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.

Description:

Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.

The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 20, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Acute ischemic stroke within 24 hours of onset of symptoms

Exclusion Criteria:

• subdural hematoma

• Transient ischemic attack

• Subarachnoid hemorrhage

• Hemorrhagic stroke

• Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) < 150 mg/dl) within 24 hours with insulin therapy, diabetic

• Ketoacidosis

• RBS less than 70 mg/dl on admission

Related Conditions & MeSH terms

• Hyperglycemia
• Stress Hyperglycemia

Intervention

Other:
• standard protocol for stroke patients
Standard protocol for stroke patients

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	National Institutes of Health Stroke Scale (NIHSS)	The NIHSS score categorized into: no stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42)	30 days
Secondary	30-days mortality	Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality	30 days