SepsisNCT06887439
Association of EASIX in Sepsis
An observational study of Sepsis and Septic Shock, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Septic Syndrome
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Dec 2025
- How long will I take part?
- 18 Months
- 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: Adult patients (≥18 years old) diagnosed with sepsis were included.
Who may be able to join
- • Patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis
- All patients over the age of 18
Who cannot join
- • Patients under the age of 18
- Patients with a history of multiple intensive care admissions
- Patients who died within 24 hours of diagnosis
- Patients diagnosed with CRF or currently treated for ARF
- Patients with deficient serum creatinine, LDH and platelet values at the time of diagnosis Patients for whom consent could not be obtained from themselves or their relatives
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli etfal research and training hospital
Istanbul, 34371
About this study
Official title: Association of Endothelial Activation and Stress Index With Mortality and Poor Prognosis in Sepsis: A Prospective Observational Study
This prospective study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis.
Read the detailed description
Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis.
The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.
- Conditions
- Sepsis, Septic Shock, Septic Syndrome
- Keywords
- sepsis, septic shock, endothelium
- Medical subject headings
- Sepsis, Shock, Septic, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sepsis group | Adult patients (≥18 years old) diagnosed with sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
The primary finding of the study was 28-day mortality after sepsis diagnosis
Measured: 28 days
Secondary outcomes (2)
Septic shock
Septic shock was defined according to the SEPSIS-3 guidelines as the need for vasopressors or inotropes in patients diagnosed with sepsis.
Measured: 28 days
Acute kidney injury
Acute kidney injury was defined according to KDIGO guidelines as a ≥0.3 mg/dL increase in serum creatinine over 48 hours, a ≥1.5-fold increase in serum creatinine over 7 days, or urine output <0.5 mL/kg/hour for 6 consecutive hours.
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 posted20 Mar 2025
- Study start1 Jun 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- AYSE SURHAN CINAR, Study chair, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887439
- Sponsor's protocol ID
- iraz-24
- Status last verified
- Jan 2026
- First submitted
- 14 Mar 2025
- Last updated
- 21 Jan 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Endothelial Activation and Stress Index With Mortality and Poor Prognosis in Sepsis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06887439
- Acronym / sponsor ID
- iraz-24
- Conditions
- Sepsis, Septic Shock, Septic Syndrome
- Keywords
- sepsis, septic shock, endothelium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Mar 2025 (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 study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis.
Detailed description
Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis.
The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis group | – | –Adult patients (≥18 years old) diagnosed with sepsis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) diagnosed with sepsis were included.
Key inclusion criteria (2 listed)
- • Patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis
Key exclusion criteria (5 listed)
- • Patients under the age of 18
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
mortality
Time frame: 28 days
The primary finding of the study was 28-day mortality after sepsis diagnosis
2 secondary outcomes
Septic shock
Time frame: 28 days
Acute kidney injury
Time frame: 28 days
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 21 Jan 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.
AYSE SURHAN CINAR study chair
şişli etfal eğitim araştırma hastanesi
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 Sisli Hamidiye Etfal 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 5 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 21 Jan 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?
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 21 Jan 2026.