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 .

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Diagnostic test: Triglyceride glucose index

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: David Ibrahim, MSc Student; Phone Number: +201063734732; Email: davidibrahimfarag@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assuit University Hospital
    • Contact: Dina Hamad, Assist.Prof; Phone Number: +201063040703; Email: dinaalihamad@yahoo.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mortality Outcome Measure	Number of Participants whom will be diagnosed with sepsis and will be admitted in the ICU	28 days

Collaborators and Investigators

• Sponsor: Egymedicalpedia
• Investigators: Study Chair: Fatema Abu-Bakre, Professor, Internal medicine, faculty of medicine, Assuit University,Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 23, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID 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