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The Diagnostic and Prognostic Value of Presepsin in Sepsis

NCT ID: NCT06180265

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-07-19

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Septic Shock

Keywords

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septic shock

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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septic shock patients

Septic shock patients undergoing major abdominal surgery treated with polymyxin-B

Group Type OTHER

presepsin, procalciton, endotoxin

Intervention Type DIAGNOSTIC_TEST

measurement of presepsin, procalciton, endotoxin plasmatic levels

Interventions

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presepsin, procalciton, endotoxin

measurement of presepsin, procalciton, endotoxin plasmatic levels

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Cotoia Antonella

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedali Riuniti

Foggia, Apulia, Italy

Site Status

Countries

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Italy

Other Identifiers

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8/C.E./2020

Identifier Type: -

Identifier Source: org_study_id