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NCT06180265 Clinical Trial

The Diagnostic and Prognostic Value of Presepsin in Sepsis

Septic Shock Clinical Trial

Official title:
PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06180265
Other study ID # 8/C.E./2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date July 19, 2023

Study information
Verified date December 2023
Source University of Foggia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

Description:

Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA). No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date July 19, 2023
Est. primary completion date July 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - caucasian patients - patients undergoing laparoscopic major abdominal surgery Exclusion Criteria: - pregnancy, - organ transplantation, - palliative care - metastatic cancer - head trauma and polytrauma - coagulopathies - use of anticoagulants - neurological disease - autoimmune disease - thyroid disease.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• presepsin, procalciton, endotoxin
measurement of presepsin, procalciton, endotoxin plasmatic levels

Locations
Country Name City State
Italy Ospedali Riuniti Foggia Puglia

Sponsors (1)
Lead Sponsor Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of mortality at 30-days incidence of mortality up to 30 days
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