NCT Number: NCT07582926
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ankara, 06010, Turkey (Türkiye)
Location status: Recruiting
Emin Gemcioglu, MD, Associate Professor
SUB_INVESTIGATOR
Hatice Z. Atlı, MD
CONTACT
Hatice Z. Atlı, MD
SUB_INVESTIGATOR
Ilkem S. Ersayin, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 28 days after ICU admission
The proportion of patients who die within 28 days following ICU admission
Time frame: Up to 90 days after ICU admission
The proportion of patients who die within 90 days following ICU admission
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.
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.
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.
Use of vasopressor agents to maintain hemodynamic stability
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
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 continue
Assessment of disease severity at ICU admission
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
Relationship between cortisol levels and laboratory markers including CRP, procalcitonin, lactate, ferritin, WBC, and albumin
Contact information is provided by the study sponsor or research team.
Ankara Etlik City Hospital
Other Gov
Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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