Sepsis and Thiol-Disulfide Balance in Emergency Department

August 14, 2025 updated by: Mehmet Alaçam, MD, Sakarya University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Adapazarı
      • Sakarya, Adapazarı, Turkey, 54050
        • Sakarya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Measurement of thiol-disulfide homeostasis parameters and inflammatory markers from serum samples.
No Intervention: Control Group
Comprised of healthy volunteers who presented to the emergency department for any reason and agreed to participate in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 monhts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Characteristics of All Participants
Time Frame: 1 week
Demographic data (age, gender, body mass index) were recorded.
1 week
Correlation of inflammatory and biochemical markers with thiol-disulfide homeostasis in sepsis
Time Frame: 10 days
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Investigators

  • Principal Investigator: Mehmet Alacam, M.D., Sakarya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

June 27, 2024

First Submitted That Met QC Criteria

August 14, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAU-ED-MA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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