Hyperglycemia as a Prognostic Factor In Acute Ischemic Stroke Patients

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04196322
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Actual Duration (Months): 19.9
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Patients	Other: observational study

Detailed Description

Patients and Methods This study was prospective study conducted in Elzaiton specialized hospital and Ain Shams University from june2016 to June 2017on 80 patients after approval of local medical ethical committee

All patients was subjected to the following

1. Full clinical history …age, sex, weight and medical history

2. GCS and motor deficit

3. Random blood glucose level at admission and 4-6 times daily during hospital stay

4. HbA1c on admission

5. Hemodynamic monitoring

6. Duration of hospital stay

7. Thirty day mortality

8. Other laboratory investigation to rule out other similar cause

9. Follow up hemorrhagic transformation Study tools: Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms will be evaluated.

On 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.

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,hemorrhagic transformation, hospital stay duration and 30-days mortality

Study Design

• Study Type: Observational
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Hyperglycemia as a Prognostic Factor In Acute Ischemic Stroke Patients
• Actual Study Start Date: Mar 15, 2016
• Actual Primary Completion Date: Oct 20, 2017
• Actual Study Completion Date: Nov 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Controlled	Other: observational study; observational study
Uncontrolled	Other: observational study; observational study

Outcome Measures

Primary Outcome Measures

1. GCS [30 days]

   GCS was assessed for 30 days

Secondary Outcome Measures

1. 30 days mortality [30 days]

   30 days mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

• Age: 40-70years

• Sex: Any sex

• Patients with acute ischemic stroke without other major comorbidities within 24 hours of onset of symptoms were evaluated.

Exclusion criteria

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanaa El Gendy	Cairo	Ain Shams University Specialized Hospital	Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanaa Mohamed Abdallah ElGendy MD, Assistant Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04196322
• Other Study ID Numbers: El Zaitoun Specialized Hospita
• First Posted: Dec 12, 2019
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Hyperglycemia; Ischemia

Study Results

No Results Posted as of Feb 4, 2021