UnknownNot Applicable

Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit

United Arab Emirates50 participantsStarted 2023-01-31

Plain-language summary

Critical illness-related corticosteroid insufficiency (CIRCI), a term coined since 2008 by Society of Critical Care Medicine (SCCM), and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive Care Unit (ICU) patients.1 Severe Sepsis with shock is a common reason for admission to ICU/hospital and may require ionotropic support.2 The current guidelines from SCCM in 2017 suggest using either random cortisol of \< 10 ug/dL (\<276 nmol/L) or change in cortisol at 60 min after cosyntropin (250 µg) administration from baseline cortisol of \<9 µg/dl (\<248 nmol/L) to assess of presence of CRCI and recommend use of hydrocortisone in these patients.3 There have been studies done to look at baseline cortisol in patient with severe pneumonia requiring ICU and they have found cortisol level of \< 15 ug/dl (\<414 nmol/L) can predict CIRCI.4 However, there is no study on assessment of baseline random cortisol levels in patients with septic shock in our local population. The current guidance from Surviving Sepsis campaign suggests a more clinical approach of adding IV corticosteroids only if there is ongoing requirement for vasopressors, which is a new change in contrast to 2016 guidelines.5 This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18; both male or female * Any nationality * Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND * who required ionotropic support within 24-48 hours of admission, AND * had a valid cortisol measurement done during this admission/encounter Exclusion Criteria: * Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock. * Patient who received steroids within 24 hours prior to sending cortisol sample * Patient with known adrenal insufficiency. * Patient on oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cortisol levels (nmol/L)

Timeframe: last 5 years

Trial details

NCT IDNCT05741762

SponsorDr Adnan Agha

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02

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