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

NCT05741762 | Unknown

• 1 other identifier: UAEU_CMHS_IM_MF2058-2022-876
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness; Adrenal Insufficiency; Septic Shock

Outcome Measures

Primary Outcomes (1)

• Cortisol levels (nmol/L)

  The aim of this study is to measure the mean random cortisol levels (in nmol/L) for patient admitted to ICU with septic shock requiring ionotropic support (who did not require any hydrocortisone during ICU stay) at Tawam hospital, United Arab Emirates to obtain a reference for our local population.

  last 5 years

Secondary Outcomes (3)

• Treatment for CRICI (total hydrocortisone dosage estimation in mg/day/patient)

  last 5 years

• outcome of patients (mortality)

  last 5 years

• steroid on discharge requirement

  last 5 years

Interventions

Retrospective chart review OTHER

The retrospective chart review will be done for patient admitted into ICU between 01/06/2017 to 01/06/2022

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Type: Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done Study location ICU, Tawam Hospital, Al Ain Study duration The retrospective chart review will be done for patient admitted into ICU between 01/06/2012 to 01/06/2022

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Adnan Agha: lead

Study Sites (1)

Tawam Hospital ICU

Al Ain City, United Arab Emirates

Location

Related Publications (3)

• Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21.

  PMID: 28940011 BACKGROUND

• Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.

  PMID: 18496365 BACKGROUND

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Joost Wiersinga W, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Yataco AC, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Executive Summary: Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):1974-1982. doi: 10.1097/CCM.0000000000005357. No abstract available.

  PMID: 34643578 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Adrenal Insufficiency; Shock, Septic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adrenal Gland Diseases; Endocrine System Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Adnan Agha

  United Arab Emirates University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 23, 2023
• Study Start: January 31, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)