- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591561
Incidence and Course of Stress Hyperglycemia in Critically Ill Children Admitted to PICU of Assiut University Children Hospital
Study Overview
Status
Conditions
Detailed Description
Critically ill patients often develop endocrine and metabolic changes, particularly disruptions of glucose homeostasis that result in hyperglycemia and hypoglycemia.Stress hyperglycemia commonly occurs in children with critical illnesses.
Stress hyperglycemia results from increased gluconeogenesis relative to the clearance of glucose as well as from the development of insulin resistance affecting glucose uptake. These mechanisms are mediated through increased production of counteracting hormones (i.e., epinephrine, norepinephrine, cortisol, glucagon, and growth hormone). Furthermore, stress hyperglycemia is associated with pro-inflammatory cytokines, oxidative stress, and therapeutic interventions. Those factors in turn inhibit the secretion of insulin by pancreatic β cells through α-adrenergic receptor stimulation, interfere with insulin receptor signaling and/or insulin-regulated glucose channels, and directly interfere with proper glucose transport and utilization in peripheral cells.
Several studies have demonstrated the association of stress hyperglycemia in critically ill children with mortality. Specifically, peak and duration of stress hyperglycemia appear to be associated with mortality. Peak blood glucose concentrations tend to be much higher in non survivors compared with survivors. Similarly, non survivors tend to have exposure to longer duration of stress hyperglycemia compared with survivors. This association of stress hyperglycemia with mortality appears across different pediatric disease states, including septic shock, burns, traumatic brain injury, post cardiac surgery, and trauma. Additionally, stress hyperglycemia is associated with longer periods of ICU and hospital stay and more frequent nosocomial infections, including surgical site infections in critically ill children. While all these studies demonstrate strong associations between stress hyperglycemia and poor clinical outcomes, they do not necessarily demonstrate a cause and effect relationship.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Critically ill children admitted to emergency and intensive care unit with blood glucose level more than or equal 200 mg\dl.
Exclusion Criteria:
- Documented cases of diabetes mellitus
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of the prevelance of stress hyperglycemia in patients admitted to pediatric intensive care unit of Assiut university children hospital
Time Frame: baseline
|
, asses its pattern ,course ,risk factors, its relation to the outcome and its management
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRS in stress hyperglycemia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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-
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-
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