Stress HyperglycemiaNCT04591561
Incidence and Course of Stress Hyperglycemia in Critically Ill Children Admitted to PICU of Assiut University Children Hospital
An observational study of Stress Hyperglycemia, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Stress Hyperglycemia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jan 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with blood glucose above 200 mg/dl on admission to the emergency department will be considered to have hyperglycemia. Data will be collected . The blood sugar values will be followed up in these children until restoration of normoglycemia. All the children will be followed up till discharge or death in case of mortality
Who may be able to join
- Critically ill children admitted to emergency and intensive care unit with blood glucose level more than or equal 200 mg\dl.
Who cannot join
- Documented cases of diabetes mellitus
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Stress Hyperglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Hamed Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591561
- Sponsor's protocol ID
- MRS in stress hyperglycemia
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Course of Stress Hyperglycemia in Critically Ill Children Admitted to PICU of Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04591561
- Acronym / sponsor ID
- MRS in stress hyperglycemia
- Conditions
- Stress Hyperglycemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with blood glucose above 200 mg/dl on admission to the emergency department will be considered to have hyperglycemia. Data will be collected . The blood sugar values will be followed up in these children until restoration of normoglycemia. All the children will be followed up till discharge or death in case of mortality
Key inclusion criteria (1 listed)
- Critically ill children admitted to emergency and intensive care unit with blood glucose level more than or equal 200 mg\dl.
Key exclusion criteria (1 listed)
- Documented cases of diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Hyperglycemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact safaa hamed (01001645692, safaa.20124126@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of the prevelance of stress hyperglycemia in patients admitted to pediatric intensive care unit of Assiut university children hospital (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.