One Year Mortality and Morbidity With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Cohort Study

August 18, 2024 updated by: Bibek Rajbhandari, Institute of medicine, Maharagjung medical campus

One Year Mortality and Morbidity Outcome With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Prospective Cohort Study

The "One Year Mortality and Morbidity Outcome with Hyperglycemia among Acute Cerebrovascular Accident Patients in Emergency Department" is an extensive prospective cohort study designed to look into how hyperglycemia affects the short- and long-term outcomes of patients who present to the emergency room with acute cerebrovascular accidents (CVAs). Worldwide, cerebrovascular accidents are a major source of both death and morbidity. Research on the long-term consequences of hyperglycemia and its association with worse outcomes during the acute period of stroke is still underway. This study aims to close this information gap by investigating the relationship between the rates of immediate short- and one-year mortality rates and morbidity and hyperglycemia at the time of CVA presentation. The research design adopts a prospective cohort approach, aligning with established guidelines to ensure methodological rigor. Systematic random sampling will be employed, with a calculated sample size of 60. Patients with acute cerebrovascular accidents who are admitted to the emergency department will be a carefully chosen group for the research. The investigators will carefully gather important data, such as baseline clinical parameters, medical history, demographics, and blood glucose levels upon admission. Throughout a year, follow-up evaluations will be carried out regularly to monitor death rates and evaluate functional and neurological results in research participants using the modified Rankin score. The study will use a structured questionnaire for data collection, involving chart review and face-to-face interviews at specified intervals. Data analysis will include bivariate analysis, logistic regression, and Kaplan-Meier analysis to identify predictors of mortality and morbidity. The ultimate goal of this research is to improve patient care, prognosis, and long-term quality of life for those impacted by this critical medical condition by illuminating the prolonged effects of hyperglycemia in acute cerebrovascular accident patients and deepening our understanding of the intricate interactions between metabolic factors and stroke outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research design and methodology of this study are meticulously crafted to explore the complex interplay between acute stroke, hyperglycemia, and their impact on mortality and morbidity. This study adopts a prospective cohort design, following a systematic approach inspired by the Critical Appraisal Skills Programme (CASP) cohort study guidelines and adhering strictly to the STROBE (Strengthening the reporting of observational studies in epidemiology), reporting standards. By implementing a quantitative research method, the study aims to provide high-quality evidence through structured and transparent methodology.

The study focuses on individuals presenting with acute stroke in the Emergency Department (ED) of Tribhuvan University Teaching Hospital (TUTH). The high patient volume and the availability of advanced diagnostic tools like CT scans make TUTH's ED an ideal setting for this research. According to internal audits, TUTH's ED receives a significant number of acute stroke patients, ensuring a robust sample for the study. The study will specifically examine acute stroke patients with concurrent hyperglycemia, utilizing a systematic random sampling technique to ensure representative and unbiased selection. The sample size was calculated using proportions from previous international studies, with adjustments for potential loss to follow-up. The final sample size is set at 60 participants, evenly divided between those with hyperglycemia and those with normal glycemic levels, allowing for meaningful comparisons.

The study's dependent variables are mortality and morbidity, assessed at short-term (1 month), mid-term (3 months), and long-term (1 year) intervals. Independent variables include demographic characteristics, clinical history, and laboratory parameters. Matching based on age, sex, stroke type, and other relevant variables is essential to minimize confounding, enhancing the validity and reliability of the study's findings. Data collection will involve chart reviews for baseline characteristics and clinical history, followed by face-to-face interviews at 1 month, 3 months, and 1 year for follow-up assessments. Laboratory analyses will be conducted for blood glucose levels, and CT scans will be utilized to confirm stroke diagnoses and assess severity. Mortality will be tracked within specified time frames, while morbidity will be assessed using the Modified Rankin Score (MRS). Clinical variables such as vital signs, GCS score, and BEFAST criteria will be recorded meticulously. Hemorrhagic and ischemic strokes will be evaluated using specific criteria, including the The intracerebral hemorrhage (ICH) score and The NIH Stroke Scale/Score (NIHSS), respectively. Participants will be recruited through a systematic process at the triage registration desk, with initial assessments based on BEFAST criteria and additional clinical signs. Blood glucose levels will be measured, followed by CT imaging to confirm stroke diagnoses. This structured flow ensures the accurate identification of eligible participants and the collection of relevant data for analysis.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, 44600
      • Kathmandu, Bagmati, Nepal, 44600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

  • Cohort: Acute Stroke Patients
  • Sampling Frame: Individuals presenting with acute stroke in the Emergency Room
  • Sampling Unit: Acute stroke patients with concurrent hyperglycemia

Description

Inclusion Criteria:

  • Individuals exhibiting BEFAST-positive symptoms - meeting at least one of the criteria within 24 hours of symptom onset.
  • Confirmation of acute stroke through CT imaging.
  • Participants aged over 40 years.

Exclusion Criteria:

  • Patients presenting with hypoglycemia
  • Transient Ischemic Attack (TIA).
  • Subdural hematoma cases.
  • Subarachnoid hemorrhage cases.
  • Diabetic Ketoacidosis.
  • Conditions mimicking stroke symptoms (e.g., sepsis, metabolic derangement, space-occupying lesions, hepatic encephalopathy).
  • History of bedridden patients.
  • Acute-on-chronic stroke cases.
  • Patients requiring assistance in daily activities.
  • History of trauma preceding the stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute stroke with hyperglycemia
Exposed group signifies acute stroke presenting in emergency department with hyperglycemia
Other: The investigators are planning to do a observational cohort study, hence won't be doing any intervention.
The investigators won't be doing any intervention since this is an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
Time Frame: 1, 3, and 12 months
Outcome Measure: Mortality rate among hyperglycemic patients with acute stroke. Unit of Measure: Percentage (%) or absolute number of deaths.
1, 3, and 12 months
Morbidity outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
Time Frame: 1, 3, and 12 months

Outcome Measure: Morbidity as assessed by the Modified Rankin Scale (MRS). Unit of Measure: MRS score (scale of 1 to 5).

Morbidity Assessment: The Modified Rankin Scale (MRS) will be used to quantify the degree of functional impairment or disability resulting from the acute stroke. The MRS score ranges from 1 to 5, with 1 indicating minimal symptoms and 5 representing severe disability or bedridden status.
1, 3, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Characteristics and Mortality Outcomes
Time Frame: 1, 3, and 12 months

Outcome Measure: Mortality rate stratified by demographic characteristics (age, sex, ethnicity, socioeconomic status).

Unit of Measure: Percentage (%) or number of deaths per group.
1, 3, and 12 months
Type of Stroke and Mortality Outcomes
Time Frame: 1, 3, and 12 months
Outcome Measure: Mortality rate stratified by type of stroke (ischemic, hemorrhagic, other). Unit of Measure: Percentage (%) or number of deaths per stroke type.
1, 3, and 12 months
Clinical History and Mortality Outcomes
Time Frame: 1, 3, and 12 months
Outcome Measure:Mortality rate stratified by clinical history (presence of comorbid conditions, previous strokes, BMI, smoking habits, alcohol consumption). Unit of Measure: Percentage (%) or number of deaths per clinical history category
1, 3, and 12 months
Laboratory Parameters and Mortality Outcomes
Time Frame: 1, 3, and 12 months
Outcome Measure: Mortality rate stratified by laboratory parameters (e.g., blood glucose levels, cholesterol levels). Unit of Measure: Percentage (%) or number of deaths per laboratory parameter range.
1, 3, and 12 months
Treatment and Mortality Outcomes
Time Frame: 1, 3, and 12 months
Outcome Measure: Mortality rate stratified by type of treatment (e.g., medications, surgical interventions). Unit of Measure: Percentage (%) or number of deaths per treatment type.
1, 3, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of medicine, Maharagjung medical campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6-11E2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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