Clinical trial NCT04767893: Diagnostic and Prognostic Biomarkers of Sepsis
Official title: Evaluation of the Role of sTREM-1 and sUPAR Biomarkers as a Diagnostic Tool and Prognostic Predictor in Sepsis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sTREM-1
sUPAR
CRP
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Our study was conducted on patients admitted to different ICUs in Sohag University Hospital who develop possible clinical signs of sepsis

Brief summary: This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.

Detailed description: Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients

Eligibility criteria: Inclusion Criteria:

* Temperature of \>38oC
* Heart rate of \>90 beats/min
* Respiratory rate of \>20 breaths/min
* Partial pressure of arterial carbon dioxide (PaCO2) of \<32 mmHg
* White blood cell (WBC) count of \>12,000 cells/mm3

Exclusion Criteria:

* HIV patients
* Patients with neutropenia \<1000 cells/mm3
* \<18 years of age.

Primary outcomes:
measure: Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
timeFrame: in the 1st day after appearance of clinical signs of infection
measure: Measurement of the serum level of sTREM-1 (ng/L) in the patients with criteria of SIRS
timeFrame: in the 7th day after appearance of clinical signs of infection
measure: Measurement of the serum level of sUPAR (ng/L) in the ICU patients
timeFrame: in the 1st day after appearance of clinical signs of infection
measure: Measurement of the serum level of sUPAR (ng/L) in the patients with criteria of SIRS
timeFrame: in the 7th day after appearance of clinical signs of infection
measure: Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
timeFrame: in the 1st day after appearance of clinical signs of infection
measure: Measurement of the serum level of CRP (mg/dl) in the patients with criteria of SIRS
timeFrame: in the 7th day after appearance of clinical signs of infection
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score designed to measure the severity of disease for adult patients admitted to intensive care units in the with criteria of SIRS
timeFrame: in the 7th day after appearance of clinical signs of infection
measure: The sequential organ failure assessment score (SOFA score) had been used to determine the extent of organ dysfunction of ICU patients with criteria of SIRS
timeFrame: in the 7th day after appearance of clinical signs of infection
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine - sohag university
Study officials:
affiliation: Sohag University
name: Nahed Fathallah, lecturer
role: PRINCIPAL_INVESTIGATOR
References: