Critical Illness Related Corticosteroids Insufficiency

January 23, 2018 updated by: Fatma mohammad, Assiut University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Critical illness related corticosteroid insufficiency
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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