Stress Hyperglycemia and Acute Ischemic Stroke

Completed

• Conditions: Stress Hyperglycemia
• Interventions: Other: standard protocol for stroke patients

• Registration Number: NCT04408768
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-17
• Primary Completion: 2019-07-09
• Study Completion: 2019-08-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Acute ischemic stroke within 24 hours of onset of symptoms

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High RBS	standard protocol for stroke patients	High RBS on ICU admission and uncontrolled blood sugar during first 24 hours
Normal RBS	standard protocol for stroke patients	Normal RBS on ICU admission and controlled blood sugar within 24 hours

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS)	30 days	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)

Secondary Outcome Measures

Name	Time	Method
30-days mortality	30 days	Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality

Trial Locations

Locations (1)

Hanaa El Gendy; 🇪🇬 Cairo, Ain Shams University Specialized Hospital, Egypt