Stress Hyperglycemia and Acute Ischemic Stroke

NCT04408768 — Completed, 80 participants, Ain Shams University

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Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients

Registry	NCT04408768
Status	Completed
Study type	Observational
Enrollment	80 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Stress Hyperglycemia
Interventions	standard protocol for stroke patients (Other)
Dates	start 2018-05-17, primary completion 2019-07-09, completion 2019-08-20, first posted 2020-05-29, last updated 2020-06-01
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Normal RBS		Other: standard protocol for stroke patients	Normal RBS on ICU admission and controlled blood sugar within 24 hours
High RBS		Other: standard protocol for stroke patients	High RBS on ICU admission and uncontrolled blood sugar during first 24 hours

standard protocol for stroke patients (Other), also known as no specific intervention: Standard protocol for stroke patients

+Outcome measures

Primary outcomes

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 outcomes

30-days mortality [30 days]: Hemorrhagic transformation, the length of hospital stay, need for mechanical ventilation and vasopressors and 30-days mortality

+Eligibility

Sex: All, ages: 50 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Hanaa El Gendy	Cairo, Ain Shams University Specialized Hospital	Egypt

My Notes

Public

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