Early Diagnosis and Prognosis of Postoperative Sepsis by Presepsin and Syndecan-1

NCT04718623 | Unknown

• 1 other identifier: presepsin,syndecan-1,sepsis
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present work is to study: Persepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis Primary aim: early diagnosis and prognosis of sepsis Secondary aim: correlate them with SOFA and qSOFA scores.

Conditions

Sepsis Following A Procedure; Diagnoses, Syndromes, and Conditions

Keywords

presepsin; syndecan-1; sepsis biomarkers; following major surgeries

Outcome Measures

Primary Outcomes (1)

• Evaluate Presepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis

  measure quantitative concentrations of Persepsin (sCD-14) and Syndecan-1 as biomarkers for early diagnosis and predict outcome

  baseline

Secondary Outcomes (1)

• correlate Persepsin (sCD-14) and Syndecan-1 with SOFA and qSOFA scores.

  baseline

Study Arms (2)

Sepsis group (SG)

with source of infection and SOFA Score more than or equal 2

Diagnostic Test: Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations

Non-Sepsis Group (NSG)

with SOFA score less than 2

Diagnostic Test: Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations

Interventions

Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations DIAGNOSTIC_TEST

Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations by ELISA technique

Non-Sepsis Group (NSG); Sepsis group (SG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged ≥18 years, of either sex, after full recovery from anaesthesia and extubated, following scheduled major abdominal, abdomino-pelvic or vascular surgeries who develop an evident source of infection whether clinical, laboratory manifestation or radiological signs of infection and/or criteria of quick SOFA (qSOFA) after admission to ICU will be included in the study.

You may qualify if:

• Adult patients aged ≥18 years, of either sex, after full recovery from anaesthesia and extubated, following scheduled major abdominal, abdomino-pelvic or vascular surgeries who develop an evident source of infection whether clinical, laboratory manifestation or radiological signs of infection and/or criteria of quick SOFA (qSOFA) after admission to ICU will be included in the study.

You may not qualify if:

• Patients aged \<18 years old.
• Patients with terminal stage of malignancy of any type.
• Immune-compromised patients e.g., on immune-suppressive therapy, acquired immunodeficiency syndrome
• Patients with end-stage liver or renal disease.
• Patients with existing infection before surgery.
• Patients with emergency surgeries.
• Pregnancy.
• Chronic inflammatory disorders e.g., sarcoidosis

Sponsors & Collaborators

• Alexandria University: lead

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous sample will be withdrawn: This will be assayed to all patients by enzyme-linked immune sorbent assay (ELISA) kit using double-antibody Sandwich-ELISA as the method. After collection of the whole blood, the blood will be left undisturbed at room temperature. This usually takes 10-20 minutes. After which the serum will be separated by centrifugation at 2000-3000 rpm for 20 minutes. Samples will be stored at -20℃ till assayed.

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hesham F Shaaban, Prof

  University of Alexandria

  STUDY DIRECTOR

• Rania Sh Swelem, Prof

  University of Alexandria

  STUDY DIRECTOR

• Hussien W Hussein, PHD

  University of Alexandria

  STUDY DIRECTOR

Central Study Contacts

HOSSAM A HASSAN

CONTACT

+201026100724; drhossam@gmail.com

Assem A Abd Rabbih, Prof

CONTACT

+201222154828

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of anaesthesia and intensive care

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: February 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01