Critical Illness Related Corticosteroids Insufficiency

Critical Illness Related Corticosteroid Insufficiency

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

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

We will recruit all critically ill patients >18 years in Critical Care Unit with APACHE II score >25 then 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): February 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: CIRCI
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: assiut univeristy13577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Prevalence of CIRCI . most common presentations of CIRCI . the best method of replacment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No