Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients

NCT ID: NCT06338124

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-04-01

Brief 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. 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 .

Conditions

Sepsis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

survivor group

About 50 patients whom will be relifed from the sepsis and will be discharged from the Intensive Care Unit

Triglyceride glucose index

Intervention Type: DIAGNOSTIC_TEST

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

Triglyceride glucose index

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fatema Abu-Bakre, Professor

Role: STUDY_CHAIR

Internal medicine, faculty of medicine, Assuit University,Egypt

Locations

Assuit University Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

David Ibrahim, MSc Student

Role: CONTACT

davidibrahimfarag@gmail.com

+201063734732

Facility Contacts

Dina Hamad, Assist.Prof

Role: primary

dinaalihamad@yahoo.com

+201063040703

Other Identifiers

David Ibrahim

Identifier Type: -

Identifier Source: org_study_id