Cortisol Levels and Mortality in Septic Shock ICU Patients

NCT07582926 | Recruiting

• 1 other identifier: AEŞH-BADEK1-2025-412
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate the prognostic value of cortisol levels and their dynamic changes in critically ill patients with sepsis and septic shock admitted to the intensive care unit. Cortisol plays a crucial role in maintaining hemodynamic stability and modulating the inflammatory response during critical illness, and relative adrenal insufficiency has been associated with worse clinical outcomes. Adult patients admitted to the intensive care unit with sepsis or septic shock will be enrolled and followed prospectively. Serum cortisol levels will be measured, and their association with clinical outcomes, including intensive care unit mortality, 28-day mortality, and 90-day mortality, will be analyzed. In addition, the relationship between cortisol levels and disease severity scores such as SOFA and APACHE, as well as laboratory parameters including inflammatory biomarkers, will be evaluated. The findings of this study are expected to contribute to the early identification of high-risk patients and improve prognostic assessment in critically ill patients with sepsis and septic shock.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; cortisol; mortality; intensive care unit

Outcome Measures

Primary Outcomes (3)

• 1.ICU mortality

  1\. ICU Mortality Measure: All-cause mortality during ICU stay Description: The proportion of patients who die during their stay in the intensive care unit

  During the first 28 days of ICU stay; if the patient is discharged from the ICU to the ward or dies earlier, the follow-up period will end at that time.

• 28 day mortality

  The proportion of patients who die within 28 days following ICU admission

  Up to 28 days after ICU admission

• 90 day mortality

  The proportion of patients who die within 90 days following ICU admission

  Up to 90 days after ICU admission

Secondary Outcomes (6)

• Length of ICU stay

  The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.

• Mechanical Ventilation Requirement

  The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.

• Vasopressor Requirement

  The duration of ICU stay will be evaluated. Although this period may vary for each patient, ICU stay is expected to end within the first 28 days for most patients. Longer ICU stays will continue to be followed and recorded in days.

• Sequential Organ Failure Assessment (SOFA) score

  The occurrence of septic shock during ICU stay will be evaluated. Although the timing may vary for each patient, septic shock is expected to occur within the first 28 days for most patients. If the duration extends beyond 28 days, follow-up will continue

• APACHE II score

  The occurrence of septic shock during ICU stay will be evaluated. Although the timing may vary for each patient, septic shock is expected to occur within the first 28 days for most patients. If the duration extends beyond 28 days, follow-up will continue

Eligibility Criteria

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

Study Population

The study population will consist of adult patients (≥18 years) admitted to the intensive care units of Ankara Etlik City Hospital with a diagnosis of sepsis or septic shock. Eligible patients will be those who have been hospitalized in the ICU for more than 24 hours and have a clinically or microbiologically confirmed source of infection. Patients will be prospectively followed during their ICU stay to evaluate cortisol levels and their association with clinical outcomes.

You may qualify if:

• Age 18 years or older
• Admission to the intensive care unit for more than 24 hours
• Presence of a clinically or microbiologically confirmed source of infection
• Diagnosis of sepsis or septic shock during ICU stay

You may not qualify if:

• Pregnancy
• Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis
• Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Ilkem S. Ersayin, MD

CONTACT

+90(543)6459248; ilkemselin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor in Internal Medicine

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)