NCT06338124

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 .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

March 22, 2024

Last Update Submit

July 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality Outcome Measure

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

    28 days

Study Arms (2)

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

non-survivor group

About 50 patients whom will be died from the sepsis in the Intensive Care Unit

Diagnostic Test: Triglyceride glucose index

Interventions

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

non-survivor groupsurvivor group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- patients whom will be diagnosed with sepsis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fatema Abu-Bakre, Professor

    Internal medicine, faculty of medicine, Assuit University,Egypt

    STUDY CHAIR

Central Study Contacts

David Ibrahim, MSc Student

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start

April 1, 2024

Primary Completion

March 15, 2025

Study Completion

April 1, 2025

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations