SepsisNCT07582926
Cortisol Levels and Mortality in Septic Shock ICU Patients
An observational study of Sepsis and Septic Shock, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 183 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis
- Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, 06010
Hatice Z. Atlı, MD, +90(530)1144086, drzeynepatli@gmail.com
Ilkem S. Ersayin, MD
About this study
Official title: Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study
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.
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, cortisol, mortality, intensive care unit
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
1.ICU mortality
- ICU Mortality Measure: All-cause mortality during ICU stay Description: The proportion of patients who die during their stay in the intensive care unit
Measured: 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
Measured: Up to 28 days after ICU admission
90 day mortality
The proportion of patients who die within 90 days following ICU admission
Measured: Up to 90 days after ICU admission
Secondary outcomes (6)
Length of ICU stay
Duration of hospitalization in the intensive care unit
Measured: 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
Whether the patient requires invasive or non-invasive mechanical ventilation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İlkem Selin Ersayin, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582926
- Sponsor's protocol ID
- AEŞH-BADEK1-2025-412
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Cortisol Levels in Critically Ill Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07582926
- Acronym / sponsor ID
- AEŞH-BADEK1-2025-412
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, cortisol, mortality, intensive care unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Known disorders of the hypothalamic-pituitary-adrenal (HPA) axis
- Known disorders affecting cortisol secretion 4.Long-term systemic glucocorticoid use (≥3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Time frame: Up to 28 days after ICU admission
The proportion of patients who die within 28 days following ICU admission
90 day mortality
Time frame: Up to 90 days after ICU admission
The proportion of patients who die within 90 days following ICU admission
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared.
Related trials for Sepsis
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A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
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Active, not recruiting
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Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilkem S. Ersayin, MD (+90(543)6459248, ilkemselin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.