Critical Illness Related Corticosteroids Insufficiency

• Conditions: Prevalence of CIRCI . Most Common Presentations of CIRCI . the Best Method of Replacment

• Registration Number: NCT03154099
• Lead Sponsor: Assiut University

Brief Summary

the detrimental impact of dysfunction is well recognized. CIRCI may be characterized by any of the following findings with delayed weaning from mechanical ventilation and hypotension refractory to fluids and vasopressors being most common Hypotension Unresponsiveness to catecholamine infusions Ventilator dependence Abdominal or flank pain High fever with negative cultures and unresponsive to antibiotic therapy Unexplained mental changes (i.e., apathy or depression) Electrolyte abnormalities (hypoglycemia, hyponatremia, hyperkalemia) Neutropenia, eosinophilia

Detailed Description

Critically ill patients are at risk for the development of Critical Illness-Related Corticosteroid Insufficiency (CIRCI). This may present as hypotension, unresponsiveness to catecholamine infusions, and/or ventilator dependence. Such patients may benefit from administration of exogenous steroids to restore their hemodynamic stability. Cortisol is vitally important to the maintenance of vascular tone, endothelial integrity, vascular permeability, and total body water distribution. It also potentiates the vasoconstrictor actions of both endogenous and exogenous catecholamines. Appropriate activation of the hypothalamic-pituitary-adrenal (HPA) axis in the critically ill patient is essential to stress adaptation and maintenance of homeostasis. Common causes of adrenal insufficiency in the critical care setting include infection, systemic inflammation, previous glucocorticoid use, and sepsis . Adrenal insufficiency among critically ill patients is also known as relative adrenal insufficiency; there is either insufficient cortisol or a cortisol level that may be high in absolute terms but insufficient to respond to the degree of stress. Thus, serum cortisol concentrations that are normal in well patients may be inappropriately low in severely sick patients. This inability to mount the appropriate response increases the risk of death during severe illness. While the incidence of CIRCI in the critically ill has been under appreciated, the detrimental impact of such dysfunction is well recognized. CIRCI may be characterized by any of the following findings with delayed weaning from mechanical ventilation and hypotension refractory to fluids and vasopressors being most common Hypotension Unresponsiveness to catecholamine infusions Ventilator dependence Abdominal or flank pain High fever with negative cultures and unresponsive to antibiotic therapy Unexplained mental changes (i.e., apathy or depression) Electrolyte abnormalities (hypoglycemia, hyponatremia, hyperkalemia) Neutropenia, eosinophilia Diagnostic criteria for CIRCI in the critically ill are not well established, but evidence suggests that modifications from standard testing are warranted. Random serum cortisol levels, free cortisol, and delta cortisol (change in baseline cortisol at 60 minutes after ACTH stimulation using 250 mcg cosyntropin) are all ways to evaluate for CIRCI.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Study Start: 2018-02-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• We will recruit all critically ill patients in Critical Care Unit with APACHE II score >25.

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Exclusion Criteria

• A known patient with adrenal insufficiency.
• Patient with a previous history of steroid therapy for more than one month.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Critical illness related corticosteroid insufficiency	one year	Prevalence of CIRCI . most common presentations of CIRCI . the best method of replacment we mesure Random serum cortisol levels and delta cortisol (change in baseline cortisol at 60 minutes after ACTH stimulation using 250 mcg cosyntropin) are all ways to evaluate for CIRCI.