Critical Illness Related Corticosteroids Insufficiency

Prevalence of CIRCI . Most Common Presentations of CIRCI . the Best Method of Replacment Clinical Trial

Official title:

Critical Illness Related Corticosteroid Insufficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03154099
• Other study ID #: assiut univeristy13577
• Status: Not yet recruiting
• Phase: N/A
• First received: May 12, 2017
• Last updated: January 23, 2018
• Start date: February 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• A known patient with adrenal insufficiency.

• Patient with a previous history of steroid therapy for more than one month.

Related Conditions & MeSH terms

• Critical Illness
• Prevalence of CIRCI . Most Common Presentations of CIRCI . the Best Method of Replacment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical illness related corticosteroid insufficiency	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.	one year