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Completed

NCT Number: NCT04408768

Stress Hyperglycemia and Acute Ischemic Stroke

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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Key information

Conditions

Stress Hyperglycemia

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard protocol for stroke patients

Other

Standard protocol for stroke patients

Other names: no specific intervention

Primary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 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

  1. 30-days mortality

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 29, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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