Clinical trial NCT06560983: One Year Mortality and Morbidity With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Cohort Study
Official title: One Year Mortality and Morbidity Outcome With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Acute Stroke
Hyperglycemia
mortality
Lead sponsor: Institute of medicine, Maharagjung medical campus
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Mortality outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
timeFrame: 1, 3, and 12 months
measure: Morbidity outcomes among hyperglycemic patients with acute stroke in the Emergency Department.
timeFrame: 1, 3, and 12 months
Secondary outcomes:
measure: Demographic Characteristics and Mortality Outcomes
timeFrame: 1, 3, and 12 months
measure: Type of Stroke and Mortality Outcomes
timeFrame: 1, 3, and 12 months
measure: Clinical History and Mortality Outcomes
timeFrame: 1, 3, and 12 months
measure: Laboratory Parameters and Mortality Outcomes
timeFrame: 1, 3, and 12 months
measure: Treatment and Mortality Outcomes
timeFrame: 1, 3, and 12 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Bibek Rajbhandari
state: Bagmati
city: Kathmandu
country: Nepal
facility: Bibek Rajbhandari
state: Bagmati
Study officials:
References:
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