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

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ClinicalTrials.gov Identifier: NCT04718623
Recruitment Status : Unknown
Verified January 2021 by hossam abousamra, Alexandria University.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
hossam abousamra, Alexandria University

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.

Condition or disease Intervention/treatment
Sepsis Following A Procedure Diagnoses, Syndromes, and Conditions Diagnostic Test: Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Presepsin and Syndecan-1 as Biomarkers for Early Diagnosis and Prognosis of Sepsis Following Major Surgeries
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
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
Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations by ELISA technique

Non-Sepsis Group (NSG)
with SOFA score less than 2
Diagnostic Test: Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations
Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations by ELISA technique




Primary Outcome Measures :
  1. Evaluate Presepsin (sCD-14) and Syndecan-1 as biomarkers following major surgeries for early diagnosis and prognosis of sepsis [ Time Frame: baseline ]
    measure quantitative concentrations of Persepsin (sCD-14) and Syndecan-1 as biomarkers for early diagnosis and predict outcome


Secondary Outcome Measures :
  1. correlate Persepsin (sCD-14) and Syndecan-1 with SOFA and qSOFA scores. [ Time Frame: baseline ]
    evaluation of level of Persepsin (sCD-14) and Syndecan-1 with SOFA and qSOFA scores to find if there is relationship between them


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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04718623


Contacts
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Contact: HOSSAM A HASSAN +201026100724 drhossam@gmail.com
Contact: Assem A Abd Rabbih, Prof +201222154828

Sponsors and Collaborators
Alexandria University
Investigators
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Study Director: 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
Publications:
Wentowski C, Mewada N, Nielsen ND. Sepsis in 2018: a review. Anaesth. Intensive Care Med. 2019;20(1):6-13
Caramore TJ, La Rocca R, Richards E. Does procalcitonin predict sepsis in critically ill patients? EBP. 2019;22(1):14-5.

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Responsible Party: hossam abousamra, specialist of anaesthesia and intensive care, Alexandria University
ClinicalTrials.gov Identifier: NCT04718623    
Other Study ID Numbers: presepsin,syndecan-1,sepsis
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Keywords provided by hossam abousamra, Alexandria University:
presepsin
syndecan-1
sepsis biomarkers
following major surgeries
Additional relevant MeSH terms:
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Sepsis
Toxemia
Disease
Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome
Inflammation