Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560983
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
One Year Mortality and Morbidity With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department A Cohort Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
One Year Mortality and Morbidity Outcome With Hyperglycemia Among Acute Cerebrovascular Accident Patients in Emergency Department A Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TUTHs ED an ideal setting for this research According to internal audits TUTHs 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 studys 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 studys 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 ScaleScore 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
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 TUTHs ED an ideal setting for this research According to internal audits TUTHs 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 studys 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 studys 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 ScaleScore 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None