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NCT Number: NCT06338124

Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients

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 .

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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 .

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triglyceride glucose index

Diagnostic Test

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

Primary outcomes

  1. Mortality Outcome Measure

    Time frame: 28 days

    Number of Participants whom will be diagnosed with sepsis and will be admitted in the ICU

Study contacts

Contact information is provided by the study sponsor or research team.

David Ibrahim, MSc Student

CONTACT

[email protected]

+201063734732

Sponsors and collaborators

Lead sponsor

Egymedicalpedia

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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