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NCT05741762
Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit
Conditions: Critical Illness, Adrenal Insufficiency, Septic Shock
Sex: All
Ages: 18 Years – 99 Years
Enrollment: 50
Sponsor: Dr Adnan Agha
Location: United Arab Emirates
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.5This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.
Eligibility Criteria
Inclusion Criteria:Age > 18; both male or femaleAny nationalityPatients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, ANDwho required ionotropic support within 24-48 hours of admission, ANDhad a valid cortisol measurement done during this admission/encounterExclusion 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 samplePatient 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
Source: ClinicalTrials.gov (NCT05741762). StuddyBuddy aggregates publicly available trial information.