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CompletedNCT07134868Updated Aug 21, 2025

Sepsis and Thiol-Disulfide Balance in Emergency Department

An interventional study of Thiol- Disulfide Blood Sample Measurement in Sepsis and Oxidative Stress, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Sakarya University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years after the study started (first participant enrolled Jun 2018, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sepsis
  • Oxidative Stress

Keywords

  • Diagnostic efficacy
  • Sepsis
  • Oxidative Stress
  • Emergency Department
  • Thiol- Disulfide Homeostasis
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 100 is close to the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients aged 18 and above who met the diagnostic criteria were included in the study

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Sepsis Group

    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.

    Diagnostic Test: Thiol- Disulfide Blood Sample Measurement

  • No intervention
    Control Group

    Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study.

Interventions

  • Diagnostic testThiol- Disulfide Blood Sample Measurement

    Measurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 monhts

Secondary outcomes

  1. General Characteristics of All Participants

    Demographic data (age, gender, body mass index) were recorded.

    Time frame: 1 week

  2. 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.

    Time frame: 10 days

07

Study locations

1 site
  • Sakarya University
    Sakarya, Adapazarı 54050, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07134868
Lead sponsor
Sakarya University
Responsible party
Mehmet Alaçam, MD (Medicine Doctor, Sakarya University) — Principal investigator
First posted
Aug 21, 2025
Start date
Jun 15, 2018
Primary completion
Sep 30, 2018
Completion
Dec 15, 2018
Last update
Aug 21, 2025

Study contacts

Mehmet Alacam, M.D.
principal investigator · Sakarya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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