SepsisNCT06338124
Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients
An observational study of Sepsis, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Triglyceride glucose index
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Apr 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome
Who may be able to join
- patients whom will be diagnosed with sepsis
Who cannot join
- patients diagnosed by hematological disease
- patients refused to participate in the research
- patients less than 18 years
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University Hospital
Asyut
Dina Hamad, Assist.Prof, +201063040703, dinaalihamad@yahoo.com
About this study
Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .
Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \Lympocyte ratio and serum lactate levels .
Read the detailed description
Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,
There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .
Triglyceride-glucose (TyG) index has emerged as a surrogate marker of insulin resistance which is often prevalent in patients with sepsis. Red blood cell distribution width (RDW) is a common clinical hematology indicator that reflects the heterogeneity of red blood cell size. As a simple and inexpensive parameter, RDW has been successfully used to predict the prognosis of many diseases, including cardiovascular disease, kidney disease, diabetes mellitus, and liver disease .
Recent studies have also shown that RDW is significantly associated with the mortality of sepsis. RDW to albumin ratio was evaluated as a novel and simple biomarker of inflammation.
-C-reactive protein (CRP) is a sensitive indicator of the body, reflecting damage and infection .
Serum albumin level drops significantly in the acute stage of infection (16). CRP/ALB ratio (CAR) could be a marker to predict mortality in sepsis.
The neutrophil-lymphocyte ratio (NLR) is an-inflammatory biomarker that can be used as an indicator of systemic inflammation. It is a simple that does not add costs to complete blood count laboratory examinations, which are performed routinely in hospitals. It was tested as a guide for the prognosis of various diseases, such as cancer, community pneumonia and sepsis.
Although these various biomarkers that have been proposed, no single clinical or biological indicator of sepsis has gained general acceptance . And to our knowledge, no previous study compared between these indicators in prediction of sepsis outcome or determined the clinical significance of combination of multiple biomarkers in prognosis of sepsis .
- Conditions
- Sepsis
- Being tested
- Triglyceride glucose index
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triglyceride glucose indexDiagnostic test
To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome.
| Study group | Role | What they receive |
|---|---|---|
| survivor group | About 50 patients whom will be relifed from the sepsis and will be discharged from the Intensive Care Unit Receives: Diagnostic Test: Triglyceride glucose index | |
| non-survivor group | About 50 patients whom will be died from the sepsis in the Intensive Care Unit Receives: Diagnostic Test: Triglyceride glucose index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Outcome Measure
Number of Participants whom will be diagnosed with sepsis and will be admitted in the ICU
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 posted29 Mar 2024
- Study start1 Apr 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fatema Abu-Bakre, Professor, Study chair, Internal medicine, faculty of medicine, Assuit University,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338124
- Sponsor's protocol ID
- David Ibrahim
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients
- ClinicalTrials.gov ID
- NCT06338124
- Acronym / sponsor ID
- David Ibrahim
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 29 Mar 2024 (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.
Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .
Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\glucose index (TyG) , Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \Lympocyte ratio and serum lactate levels .
Detailed description
Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,
There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .
Triglyceride-glucose (TyG) index has emerged as a surrogate marker of insulin resistance which is often prevalent in patients with sepsis. Red blood cell distribution width (RDW) is a common clinical hematology indicator that reflects the heterogeneity of red blood cell size. As a simple and inexpensive parameter, RDW has been successfully used to predict the prognosis of many diseases, including cardiovascular disease, kidney disease, diabetes mellitus, and liver disease .
Recent studies have also shown that RDW is significantly associated with the mortality of sepsis. RDW to albumin ratio was evaluated as a novel and simple biomarker of inflammation.
-C-reactive protein (CRP) is a sensitive indicator of the body, reflecting damage and infection .
Serum albumin level drops significantly in the acute stage of infection (16). CRP/ALB ratio (CAR) could be a marker to predict mortality in sepsis.
The neutrophil-lymphocyte ratio (NLR) is an-inflammatory biomarker that can be used as an indicator of systemic inflammation. It is a simple that does not add costs to complete blood count laboratory examinations, which are performed routinely in hospitals. It was tested as a guide for the prognosis of various diseases, such as cancer, community pneumonia and sepsis.
Although these various biomarkers that have been proposed, no single clinical or biological indicator of sepsis has gained general acceptance . And to our knowledge, no previous study compared between these indicators in prediction of sepsis outcome or determined the clinical significance of combination of multiple biomarkers in prognosis of sepsis .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survivor group | – | Diagnostic Test: Triglyceride glucose indexAbout 50 patients whom will be relifed from the sepsis and will be discharged from the Intensive Care Unit |
| non-survivor group | – | Diagnostic Test: Triglyceride glucose indexAbout 50 patients whom will be died from the sepsis in the Intensive Care Unit |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome
Key inclusion criteria (1 listed)
- patients whom will be diagnosed with sepsis
Key exclusion criteria (3 listed)
- patients diagnosed by hematological disease
- patients refused to participate in the research
- patients less than 18 years
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 |
|---|---|---|
| Triglyceride glucose indexTo evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome. | Diagnostic test | non-survivor group, survivor group |
Primary outcome
Mortality Outcome Measure
Time frame: 28 days
Number of Participants whom will be diagnosed with sepsis and will be admitted in the ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: Undecided
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.
Fatema Abu-Bakre, Professor study chair
Internal medicine, faculty of medicine, Assuit University,Egypt
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, run by Egymedicalpedia at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Ibrahim, MSc Student (+201063734732, davidibrahimfarag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Outcome Measure (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 11 Jul 2024.