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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04591561
Other study ID # MRS in stress hyperglycemia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date January 1, 2022

Study information

Verified date October 2020
Source Assiut University
Contact safaa hamed
Phone 01001645692
Email safaa.20124126@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Detection of the prevelance of stress hyperglycemia in patients admitted to pediatric intensive care unit of Assiut university children hospital , asses its pattern ,course ,risk factors, its relation to the outcome and its management.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of the prevelance of stress hyperglycemia in patients admitted to pediatric intensive care unit of Assiut university children hospital , asses its pattern ,course ,risk factors, its relation to the outcome and its management baseline
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