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

NCT ID: NCT06560983

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-12-15

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute stroke with hyperglycemia

Exposed group signifies acute stroke presenting in emergency department with hyperglycemia

The investigators are planning to do a observational cohort study, hence won't be doing any intervention.

Intervention Type: OTHER

The investigators won't be doing any intervention since this is an observational study.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of medicine, Maharagjung medical campus

OTHER

Sponsor Role: lead

Responsible Party

Bibek Rajbhandari

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bibek Rajbhandari

Kathmandu, Bagmati, Nepal

Site Status: NOT_YET_RECRUITING

Bibek Rajbhandari

Kathmandu, Bagmati, Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Bibek Rajbhandari, masters

Role: CONTACT

bibekrajbhandarimg@gmail.com

9851281884

Facility Contacts

Bibek Rajbhandari, MD

Role: primary

bibekrajbhandarimg@gmail.com

9851281884

Bibek Rajbhandari, MD

Role: primary

bibekrajbhandarimg@gmail.com

9851281884

References

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Goulart AC, Bensenor IM, Fernandes TG, Alencar AP, Fedeli LM, Lotufo PA. Early and one-year stroke case fatality in Sao Paulo, Brazil: applying the World Health Organization's stroke STEPS. J Stroke Cerebrovasc Dis. 2012 Nov;21(8):832-8. doi: 10.1016/j.jstrokecerebrovasdis.2011.04.017. Epub 2011 Jun 25.

Reference Type: BACKGROUND

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Other Identifiers

6-11E2

Identifier Type: -

Identifier Source: org_study_id