Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients

July 9, 2024 updated by: Egymedicalpedia

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assuit University Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome

Description

Inclusion Criteria:

- patients whom will be diagnosed with sepsis

Exclusion Criteria:

  • patients diagnosed by hematological disease
  • patients refused to participate in the research
  • patients less than 18 years

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
survivor group
About 50 patients whom will be relifed from the sepsis and will be discharged from the Intensive Care Unit
Diagnostic test: Triglyceride glucose index
To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome.
non-survivor group
About 50 patients whom will be died from the sepsis in the Intensive Care Unit
Diagnostic test: Triglyceride glucose index
To evaluate the role of various laboratory biomarkers ( TyG , RAR , CAR, N\L ratio, CRP, Serum lactate )in prediction of sepsis outcome.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality Outcome Measure
Time Frame: 28 days
Number of Participants whom will be diagnosed with sepsis and will be admitted in the ICU
28 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Egymedicalpedia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fatema Abu-Bakre, Professor, Internal medicine, faculty of medicine, Assuit University,Egypt

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • David Ibrahim

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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