Cortisol Levels and Mortality in Septic Shock ICU Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy
Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis
Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
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.2
28 day mortality
The proportion of patients who die within 28 days following ICU admission
Time frame
Up to 28 days after ICU admission3
90 day mortality
The proportion of patients who die within 90 days following ICU admission
Time frame
Up to 90 days after ICU admissionSecondary outcomes
1
Length of ICU stay
Duration of hospitalization in the intensive care unit
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.2
Mechanical Ventilation Requirement
Whether the patient requires invasive or non-invasive mechanical ventilation
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.3
Vasopressor Requirement
Use of vasopressor agents to maintain hemodynamic stability
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.4
Sequential Organ Failure Assessment (SOFA) score
Assessment of organ dysfunction severity using 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 continueSponsors and contacts
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Source ClinicalTrials.gov