Sepsis, Septic Shock
Conditions
Keywords
sepsis, septic shock, cortisol, mortality, intensive care unit
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.
Interventions
None listed
Sponsors
Ankara Etlik City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1.ICU mortality | 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. | 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 |
| 28 day mortality | Up to 28 days after ICU admission | The proportion of patients who die within 28 days following ICU admission |
| 90 day mortality | Up to 90 days after ICU admission | The proportion of patients who die within 90 days following ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Duration of hospitalization in the intensive care unit |
| 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. | Whether the patient requires invasive or non-invasive mechanical ventilation |
| 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. | Use of vasopressor agents to maintain hemodynamic stability |
| 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 | Assessment of organ dysfunction severity using SOFA score |
| 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 | Assessment of disease severity at ICU admission |
| Association between cortisol levels and laboratory parameters | 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 | Relationship between cortisol levels and laboratory markers including CRP, procalcitonin, lactate, ferritin, WBC, and albumin |
Countries
Turkey (Türkiye)
Contacts
CONTACTIlkem S. Ersayin, MD
Outcome results
None listed