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NCT Number: NCT06586372

CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient With Sepsis in Assiut University Hospitals

the goal of this study is to asses the value of biomarker (CRP, CRP/Alb ratio, N/L ratio) in predictor of the outcome in normotensive patients with sepsis.

The main question it aims to answer is:

Does biomarker (CRP, CRP/Alb ratio, N/L ratio) can predict the outcome in patients with sepsis ?

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Key information

About this study

Sepsis is an unusual systemic reaction to what is sometimes an otherwise ordinary infection, and it probably represents a pattern of response by the immune system to injury. A hyper-inflammatory response is followed by an immunosuppressive phase during which multiple organ dysfunction is present and the patient is susceptible to nosocomial infection.

A biomarker describes a measurable indicator of a patient's clinical condition that can be measured accurately and reproducibly. Biomarkers offer utility for diagnosis, prognosis, early disease recognition, risk stratification, appropriate treatment (theranostics), and trial enrichment for patients with sepsis or suspected sepsis C-reactive protein (CRP) is an acute-phase protein that is produced following stimulation by various cytokines in response to infection, ischemia, trauma, and other inflammatory conditions . High CRP levels have been studied in relation to prognosis and mortality in critically ill patients . On the other hand, low serum albumin is known to be associated with poor prognosis and mortality . Based on this knowledge, we speculated that the ratio of CRP to albumin could be used as a predictive marker for mortality.

Recently, the CRP/albumin ratio, a combination of markers for systemic inflammation and nutritional status, has been extensively studied as an independent prognostic marker in patients with infection, malignancy, and other diseases . However, there are relatively few studies conducted focusing on critical care patients in the ICU Among the plethora of biomarkers available to clinicians investigating septic patients in the Emergency Department (ED), white blood cell count (WBC) are always taken into consideration due to their availability and low cost. Serial measurement of RP, is useful for clinicians' decision-making, as its serum levels correlate with the syndrome evo-lution .Neutrophil-to-lymphocyte ratio (NLR) calculated from the complete blood count seems to be a reasonable tool for assessment during the sepsis course (8, 9).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with sepsis with normal blood pressure

Exclusion criteria

  • 1) Patients with history of corticosteroid therapy or antibiotic use before admission.
  • Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .

3)Patients with shock

Treatment and study plan

Primary outcomes

  1. CRP level in patients with sepsis

    Time frame: baseline

  2. CRP/Alb ratio level in patients with sepsis

    Time frame: baseline

Study contacts

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

Esraa Ahmed Mohamed Gomaa, resident doctors

CONTACT

[email protected]

+201155339230

Nour Eldine Abd-Elaseame, professor

CONTACT

[email protected]

+201005035180

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient With Sepsis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 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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