Clinical trial NCT06586372: CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient with Sepsis in Assiut University Hospitals
Official title: CRP,CRP/Alb Ratio, N/L Ratio in Predictors of Both Systemic Infection and Survival in Patient with Sepsis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Systemic Infection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: the patients will be diagnosed according to international criteria and sepsis-3 definitions

Brief summary: 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 ?

Detailed description: 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\&#39;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).

Eligibility criteria: Inclusion Criteria:

* Patients with sepsis with normal blood pressure

Exclusion Criteria:

* 1) Patients with history of corticosteroid therapy or antibiotic use before admission.

  2) Patients with hematologic disorders, malignant diseases, chemotherapy or radiotherapy within the previous month .

  3)Patients with shock

Primary outcomes:
measure: CRP level in patients with sepsis
timeFrame: baseline
measure: CRP/Alb ratio level in patients with sepsis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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