NCT04408768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 26, 2020

Last Update Submit

May 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 30-days mortality

    30 days

Study Arms (2)

Normal RBS

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

Other: standard protocol for stroke patients

High RBS

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

Other: standard protocol for stroke patients

Interventions

Standard protocol for stroke patients

Also known as: no specific intervention
High RBSNormal RBS

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study included eighty acute ischemic stroke patients who presented within 24 hours of onset of symptoms. They were equally divided into two groups; group A included patients with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h, while group B included those with high RBS on ICU admission and uncontrolled blood sugar during first 24 h.

You may qualify if:

  • Acute ischemic stroke within 24 hours of onset of symptoms

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 29, 2020

Study Start

May 17, 2018

Primary Completion

July 9, 2019

Study Completion

August 20, 2019

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations