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Recruiting NCT07582926

Cortisol Levels and Mortality in Septic Shock ICU Patients

— Observational Sepsis Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sepsis, Septic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study

Overview

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.

Primary outcome measures

  • 1.ICU mortality [Time frame: 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 [Time frame: Up to 28 days after ICU admission]
  • 90 day mortality [Time frame: Up to 90 days after ICU admission]
Secondary outcome measures (6)
  • Length of ICU stay [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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]
  • Association between cortisol levels and laboratory parameters [Time frame: 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

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07582926 · AEŞH-BADEK1-2025-412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗