Stress Hyperglycemia and Acute Ischemic Stroke

NCT ID: NCT04408768

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-17

Study Completion Date

2019-08-20

Brief Summary

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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

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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.

Conditions

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Stress Hyperglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal RBS

Normal RBS on ICU admission and controlled blood sugar within 24 hours

standard protocol for stroke patients

Intervention Type OTHER

Standard protocol for stroke patients

High RBS

High RBS on ICU admission and uncontrolled blood sugar during first 24 hours

standard protocol for stroke patients

Intervention Type OTHER

Standard protocol for stroke patients

Interventions

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standard protocol for stroke patients

Standard protocol for stroke patients

Intervention Type OTHER

Other Intervention Names

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no specific intervention

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hanaa Mohamed Abdallah ElGendy MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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El Zaiton Specialized Hospital

Identifier Type: -

Identifier Source: org_study_id

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