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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay | Duration of hospitalization in the intensive care unit | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilkem S. Ersayin, MD | Contact | +90(543)6459248 | ilkemselin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | 06010 | Turkey (Türkiye) |
Individual participant data (IPD) will not be shared.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Mechanical Ventilation Requirement |
Whether the patient requires invasive or non-invasive mechanical ventilation |
| 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 | Use of vasopressor agents to maintain hemodynamic stability | 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 | Assessment of organ dysfunction severity using 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 | Assessment of disease severity at ICU admission | 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 | Relationship between cortisol levels and laboratory markers including CRP, procalcitonin, lactate, ferritin, WBC, and albumin | 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |