Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-15
Brief Title:
Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Impact of Blood Glucose Levels on in ICU Morbidity and Mortality in Patients With Acute Decompensated Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure
Detailed Description:
Stress hyperglycemia is a physiological response of blood glucose levels to stressful events or severe diseases through enhanced inflammatory or neuro-hormonal activation typically reflecting the severity of the corresponding disease
Diabetes mellitus may lead to hyperglycemia However it can happen as a result of stress hormones in crucial situations as well as in illness states and is referred to as Stress Hyperglycemia Other names for this syndrome include New onset Hyperglycemia In hospital Hyperglycemia Admission Hyperglycemia New Hyperglycemia and reactive Hyperglycemia The prevalence of admission hyperglycaemia ranges from 25 to 50 depending on the hyperglycaemia definition cut-off adopted The American Heart Association and the Endocrine Society Clinical Guidelines defined stress hyperglycaemia as a random plasma glucose level above 140 mgdL at any given time for both diabetic and nondiabetic hospitalized patientsStudies have shown that an elevated admission blood glucose level in correlation with a specific condition such as myocardial infarction stroke heart failure or pneumonia is associated with a higher in-hospital mortality increased length of hospital stay and a higher rate of in-hospital complications
Heart failure HF is a complex clinical syndrome that results from structural or functional impairment of ventricular filling or ejection Also HF is a progressive condition with intermittent acute decompensation leading to poor prognosis despite established guideline-directed therapyAcute decompensated heart failure is a common reason for frequent hospital admission and has been associated with increased short-term mortality and poor long-term prognosis Admission hyperglycaemia can be useful in identifying high-risk group of acute heart failure or in the risk stratification of acute heart failure In addition to age obesity and diabetes have been identified as important risk factors for heart failure Heart failure often manifests as the first cardiovascular event in people with type 2 diabetesSeveral potential mechanisms contributing to the development of heart failure in diabetes include renin-angiotensin-aldosterone system RAAS activation mitochondrial dysfunction oxidative stress inflammation changes in intracellular calcium homeostasis increased formation of advanced glycation end products and myocardial energy substrate alterations including increased free fatty acid utilization decreased glucose utilization and increased oxygen consumption resulting in decreased cardiac efficiency
Dysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients
It is also to be noted that individuals with HF and pre-diabetes have a higher risk of all-cause mortality and cardiac outcomes compared to those with normoglycemia
Diabetes mellitus may lead to hyperglycemia However it can happen as a result of stress hormones in crucial situations as well as in illness states and is referred to as Stress Hyperglycemia Other names for this syndrome include New onset Hyperglycemia In hospital Hyperglycemia Admission Hyperglycemia New Hyperglycemia and reactive Hyperglycemia The prevalence of admission hyperglycaemia ranges from 25 to 50 depending on the hyperglycaemia definition cut-off adopted The American Heart Association and the Endocrine Society Clinical Guidelines defined stress hyperglycaemia as a random plasma glucose level above 140 mgdL at any given time for both diabetic and nondiabetic hospitalized patientsStudies have shown that an elevated admission blood glucose level in correlation with a specific condition such as myocardial infarction stroke heart failure or pneumonia is associated with a higher in-hospital mortality increased length of hospital stay and a higher rate of in-hospital complications
Heart failure HF is a complex clinical syndrome that results from structural or functional impairment of ventricular filling or ejection Also HF is a progressive condition with intermittent acute decompensation leading to poor prognosis despite established guideline-directed therapyAcute decompensated heart failure is a common reason for frequent hospital admission and has been associated with increased short-term mortality and poor long-term prognosis Admission hyperglycaemia can be useful in identifying high-risk group of acute heart failure or in the risk stratification of acute heart failure In addition to age obesity and diabetes have been identified as important risk factors for heart failure Heart failure often manifests as the first cardiovascular event in people with type 2 diabetesSeveral potential mechanisms contributing to the development of heart failure in diabetes include renin-angiotensin-aldosterone system RAAS activation mitochondrial dysfunction oxidative stress inflammation changes in intracellular calcium homeostasis increased formation of advanced glycation end products and myocardial energy substrate alterations including increased free fatty acid utilization decreased glucose utilization and increased oxygen consumption resulting in decreased cardiac efficiency
Dysregulation of hyperglycemia and glycemic variability are associated with an increased risk of mortality in critically ill patients
It is also to be noted that individuals with HF and pre-diabetes have a higher risk of all-cause mortality and cardiac outcomes compared to those with normoglycemia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None