SepsisNCT07134868
Sepsis and Thiol-Disulfide Balance in Emergency Department
A study testing Thiol- Disulfide Blood Sample Measurement in people with Sepsis and Oxidative Stress, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effectiveness of thiol-disulfide homeostasis in predicting diagnosis and mortality in sepsis patients, and to compare it with other inflammatory markers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Oxidative Stress
- What is being tested?
- Thiol- Disulfide Blood Sample Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 15 Dec 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above who met the diagnostic criteria were included in the study
Who cannot join
- Who did not meet the criteria for sepsis diagnosis according to the quick Sequential Organ Failure Assessment score
- Individuals with malignancy, acute coronary syndrome, acute cerebrovascular event, acute/chronic kidney/liver failure, rheumatologic diseases, febrile neutropenia, immunosuppressive disorders, corticosteroid use, and those
- Individuals with a history of antibiotic use within the last week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic Efficacy of Thiol-Disulfide Homeostasis in Sepsis Patients
The aim of this study was to determine the effectiveness of thiol-disulfide homeostasis in predicting diagnosis and mortality in sepsis patients, and to compare it with other inflammatory markers.
Read the detailed description
Sepsis is a serious illness with high mortality rates triggered by infection-associated pathogenesis involving oxidative stress dysfunction. This study aims to elucidate the diagnostic efficacy of changes in thiol-disulfide homeostasis, its predictive role in mortality, relationship with other inflammatory parameters in sepsis patients in emergency department.
In prospective, randomized controlled study, 50 patients diagnosed with sepsis according to the Sepsis-3 guidelines who presented emergency department were compared with a control group of 50 healthy volunteers. Thiol-disulfide homeostasis parameters, including total thiol, native thiol, disulfide levels, reduced thiol, oxidized thiol, and thiol oxidation-reduction ratios, were examined. Additionally, inflammatory blood parameters (C-reactive protein, procalcitonin, lactate) and mortality durations were compared with thiol-disulfide homeostasis.
The objective of this study was to examine the effectiveness of thiol-disulfide homeostasis in forecasting diagnosis and mortality in sepsis patients, and to compare it against other inflammatory markers.
- Conditions
- Sepsis, Oxidative Stress
- Being tested
- Thiol- Disulfide Blood Sample Measurement
- Keywords
- Diagnostic efficacy, Sepsis, Oxidative Stress, Emergency Department, Thiol- Disulfide Homeostasis
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiol- Disulfide Blood Sample MeasurementDiagnostic test
Measurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis Group | Active comparator | Consisted of patients diagnosed with sepsis (defined as those presenting to the emergency department with suspected infection and scoring two or higher on the quick Sequential Organ Failure Assessment scoring system according to the Sepsis-3 guidelines) and who agreed to participate in the study. Receives: Diagnostic Test: Thiol- Disulfide Blood Sample Measurement |
| Control Group | No intervention | Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of serum thiol-disulfide homeostasis parameters in sepsis
Measurement of serum total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels in patients with sepsis and healthy controls at the time of admission, and comparison between groups to evaluate diagnostic performance.
Measured: 2 monhts
Secondary outcomes (2)
General Characteristics of All Participants
Demographic data (age, gender, body mass index) were recorded.
Measured: 1 week
Correlation of inflammatory and biochemical markers with thiol-disulfide homeostasis in sepsis
Initial blood samples collected from sepsis patients were analyzed to measure total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels. These thiol-disulfide homeostasis parameters were then compared and correlated with standard laboratory inflammatory markers, including C-reactive protein (CRP), procalcitonin, and lactate, to evaluate their relationships.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start15 Jun 2018
- Primary completion30 Sep 2018
- Study completion15 Dec 2018
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 Sakarya UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Alaçam, MD, Sakarya University
- Investigators
- Mehmet Alacam, M.D., Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134868
- Sponsor's protocol ID
- SAU-ED-MA-01
- Status last verified
- Aug 2025
- First submitted
- 27 Jun 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Efficacy of Thiol-Disulfide Homeostasis in Sepsis Patients
- ClinicalTrials.gov ID
- NCT07134868
- Acronym / sponsor ID
- SAU-ED-MA-01
- Conditions
- Sepsis, Oxidative Stress
- Keywords
- Diagnostic efficacy, Sepsis, Oxidative Stress, Emergency Department, Thiol- Disulfide Homeostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 21 Aug 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.
The aim of this study was to determine the effectiveness of thiol-disulfide homeostasis in predicting diagnosis and mortality in sepsis patients, and to compare it with other inflammatory markers.
Detailed description
Sepsis is a serious illness with high mortality rates triggered by infection-associated pathogenesis involving oxidative stress dysfunction. This study aims to elucidate the diagnostic efficacy of changes in thiol-disulfide homeostasis, its predictive role in mortality, relationship with other inflammatory parameters in sepsis patients in emergency department.
In prospective, randomized controlled study, 50 patients diagnosed with sepsis according to the Sepsis-3 guidelines who presented emergency department were compared with a control group of 50 healthy volunteers. Thiol-disulfide homeostasis parameters, including total thiol, native thiol, disulfide levels, reduced thiol, oxidized thiol, and thiol oxidation-reduction ratios, were examined. Additionally, inflammatory blood parameters (C-reactive protein, procalcitonin, lactate) and mortality durations were compared with thiol-disulfide homeostasis.
The objective of this study was to examine the effectiveness of thiol-disulfide homeostasis in forecasting diagnosis and mortality in sepsis patients, and to compare it against other inflammatory markers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis Group | Active comparator | Diagnostic Test: Thiol- Disulfide Blood Sample MeasurementConsisted of patients diagnosed with sepsis (defined as those presenting to the emergency department with suspected infection and scoring two or higher on the quick Sequential Organ Failure Assessment scoring system according to the Sepsis-3 guidelines) and who agreed to participate in the study. |
| Control Group | No intervention | –Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 and above who met the diagnostic criteria were included in the study
Key exclusion criteria (3 listed)
- Who did not meet the criteria for sepsis diagnosis according to the quick Sequential Organ Failure Assessment score
- Individuals with malignancy, acute coronary syndrome, acute cerebrovascular event, acute/chronic kidney/liver failure, rheumatologic diseases, febrile neutropenia, immunosuppressive disorders, corticosteroid use, and those
- Individuals with a history of antibiotic use within the last week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiol- Disulfide Blood Sample MeasurementMeasurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples. | Diagnostic test | Sepsis Group |
Primary outcome
Diagnostic value of serum thiol-disulfide homeostasis parameters in sepsis
Time frame: 2 monhts
Measurement of serum total thiol, native thiol, disulfide, reduced thiol, and oxidized thiol levels in patients with sepsis and healthy controls at the time of admission, and comparison between groups to evaluate diagnostic performance.
2 secondary outcomes
General Characteristics of All Participants
Time frame: 1 week
Correlation of inflammatory and biochemical markers with thiol-disulfide homeostasis in sepsis
Time frame: 10 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 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Sepsis
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Mehmet Alacam, M.D. principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiol- Disulfide Blood Sample Measurement in people with Sepsis and Oxidative Stress, run by Sakarya University 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 1 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 21 Aug 2025. 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?
Diagnostic value of serum thiol-disulfide homeostasis parameters in sepsis (time frame: 2 monhts). 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 Aug 2025.