SepsisNCT07521306
Biomarkers for Predicting Mortality in Patients With Suspected Sepsis
An observational study of Sepsis and Mortality, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study aimes to analyze the association of a number of routinely performed biomarkers with mortality in patients admitted to ICU with suspected sepsis. The study includes patients >18 years of age, who had been admitted to the ICU with suspected sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Mortality, Biomarkers
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 is patients older than 18 years of age who have primary diagnoses of admission to intensive care unit are infection and suspected sepsis.
Who may be able to join
- >18 years of age
- admission to the ICU with suspected sepsis
Who cannot join
- ICU admission following cardiopulmonary resuscitation or cardiac surgery
- Having a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Interruption of the treatment process because of transfer to another healthcare facility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Training and Research Hospital
Niğde, Niğde Province, 51200
About this study
Official title: The Use of Biomarkers for Predicting Mortality in Patients With Suspected Sepsis
This retrospective study aimes to analyze the association of a number of routinely performed biomarkers with mortality in patients admitted to ICU with suspected sepsis.
The study includes patients >18 years of age, who had been admitted to the ICU with suspected sepsis. At ICU admission, baseline levels of PCT, CRP, albumin and lactate as well as WBC, neutrophil and lymphocyte counts will recorded.
Read the detailed description
This study aimes to investigate the association of a number of biomarkers with 28-day mortality of patients admitted to the ICU with suspected sepsis, which included C-reactive protein (CRP), procalcitonin (PCT), WBC count, neutrophil count, lymphocyte count, albumin and lactate.
Data will obtained from hospital electronic medical records. Data includes age, sex, duration of ICU stay, origin of infection (urinary, abdominal, pulmonary, soft tissue, central nervous system, catheter-related, mixed, others) and comorbidities (hypertension, diabetes mellitus, chronic obstructive pulmonary disease, chronic renal failure, heart failure, coronary artery disease, malignancies, others). Whether patients were admitted to the ICU following a scheduled surgery or emergency surgery will also recorded.
At admission, baseline levels of PCT, CRP, albumin and lactate as well as WBC, neutrophil and lymphocyte counts will recorded.
The primary outcome is 28-day mortality. For patients with multiple episodes requiring ICU admission, only the most recent episode will taken into consideration.
- Conditions
- Sepsis, Mortality, Biomarkers
- Keywords
- Sepsis biomarkers, Mortality
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
mortality within 28 days after intensive care admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 May 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sümeyye Uğur, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521306
- Sponsor's protocol ID
- SU2024
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Biomarkers for Predicting Mortality in Patients With Suspected Sepsis
- ClinicalTrials.gov ID
- NCT07521306
- Acronym / sponsor ID
- SU2024
- Conditions
- Sepsis, Mortality, Biomarkers
- Keywords
- Sepsis biomarkers, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Apr 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 retrospective study aimes to analyze the association of a number of routinely performed biomarkers with mortality in patients admitted to ICU with suspected sepsis.
The study includes patients >18 years of age, who had been admitted to the ICU with suspected sepsis. At ICU admission, baseline levels of PCT, CRP, albumin and lactate as well as WBC, neutrophil and lymphocyte counts will recorded.
Detailed description
This study aimes to investigate the association of a number of biomarkers with 28-day mortality of patients admitted to the ICU with suspected sepsis, which included C-reactive protein (CRP), procalcitonin (PCT), WBC count, neutrophil count, lymphocyte count, albumin and lactate.
Data will obtained from hospital electronic medical records. Data includes age, sex, duration of ICU stay, origin of infection (urinary, abdominal, pulmonary, soft tissue, central nervous system, catheter-related, mixed, others) and comorbidities (hypertension, diabetes mellitus, chronic obstructive pulmonary disease, chronic renal failure, heart failure, coronary artery disease, malignancies, others). Whether patients were admitted to the ICU following a scheduled surgery or emergency surgery will also recorded.
At admission, baseline levels of PCT, CRP, albumin and lactate as well as WBC, neutrophil and lymphocyte counts will recorded.
The primary outcome is 28-day mortality. For patients with multiple episodes requiring ICU admission, only the most recent episode will taken into consideration.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients older than 18 years of age who have primary diagnoses of admission to intensive care unit are infection and suspected sepsis.
Key inclusion criteria (2 listed)
- >18 years of age
- admission to the ICU with suspected sepsis
Key exclusion criteria (3 listed)
- ICU admission following cardiopulmonary resuscitation or cardiac surgery
- Having a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Interruption of the treatment process because of transfer to another healthcare facility
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
28-day mortality
Time frame: 28 days
mortality within 28 days after intensive care admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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. This study is not recruiting at the moment.
Sümeyye Uğur principal investigator
Antalya Training and Research Hospital
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 Mortality, run by Antalya Training and Research 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 2 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: finished, as of the sponsor's last update on 9 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). 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 9 Apr 2026.