NCT04196322

Brief Summary

Background: Hyperglycemia is encountered in 20% to 40% of acute stroke patients, with or without a pre-morbid diagnosis of diabetes mellitus. Hyperglycemia is a risk factor for infarct expansion and poor outcome through the first 72 hours of onset in both diabetics and non-diabetics patients. This study was done to evaluate the glycemic status after acute ischemic stroke and assess its rule in influencing stroke outcome as regards the duration of hospital stay, motor deficit and mortality. Methods: This retrospective study was conducted in Elzaiton specialized hospital from June 2016 to June 2017on 80 patients after approval of local medical ethical committee. Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were included and divided into two groups, controlled group (Random blood suger not more than 150 mg/dl) and uncontrolled group ( Random blood suger more than 150 mg/dl). All patients were evaluated for GCS as a primary outcome and for hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors,hospital stay and mortality as secondary outcomes.

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 Mar 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

December 6, 2019

Last Update Submit

February 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • GCS

    GCS was assessed for 30 days

    30 days

Secondary Outcomes (1)

  • 30 days mortality

    30 days

Study Arms (2)

Controlled

Other: observational study

Uncontrolled

Other: observational study

Interventions

observational study

ControlledUncontrolled

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated. At ICU admission the random blood sugar was recorded and categorized to less than 150mg/dl (accepted) and more than 150mg/dl(not controlled). Also serial Random blood sugar daily was recorded and categorized to accepted or good control if less than 150mg/dl and not controlled if more than 150mg/dl. Patients were divided into 2 groups Patients with accepted random blood sugar at admission and controlled blood sugar during hospital stay (B) Patients with increased random blood sugar at admission and poor blood sugar control during hospital stay These data were collected and patients were observed as regards duration of hospital stay, motor deficit improvement or worsening using Rating scale for muscle strength

You may qualify if:

  • Age: 40-70years
  • Sex: Any sex
  • Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were evaluated.

You may not qualify if:

  • Subdural heamatoma, metabolic causes or transient ischemic attack
  • Sub arachnoid heamorrage
  • Heamorragic stroke
  • Patients with major comorbidities at admission as end stage liver disease, end stage renal disease and malignant hypertension
  • Patients with hyperglycemia at admission and controlled blood sugar during hospital stay
  • Patients with DKA or hypoglycemia (RBS less than 70 mg dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

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

December 6, 2019

First Posted

December 12, 2019

Study Start

March 15, 2016

Primary Completion

October 20, 2017

Study Completion

November 12, 2017

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations