The Diagnostic and Prognostic Value of Presepsin in Sepsis | NCT06180265

Studies
The Diagnostic and Prognostic Value of Presepsin in Sepsis

NCT06180265

Sponsor

University of Foggia

Status

Completed

Last Update Posted

Dec 22, 2023Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Septic Shock

Interventions

presepsin, procalciton, endotoxin

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Actual

Primary Completion Date

Jul 19, 2023Actual

Completion Date

Jul 19, 2023Actual

First Submitted Date

Jul 25, 2023

First Submission Date that Met QC Criteria

Dec 21, 2023

First Posted Date

Dec 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2023

Last Update Posted Date

Dec 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
septic shock patients	Other	Septic shock patients undergoing major abdominal surgery treated with polymyxin-B	Diagnostic Test: presepsin, procalciton, endotoxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
presepsin, procalciton, endotoxin	Diagnostic Test	measurement of presepsin, procalciton, endotoxin plasmatic levels	septic shock patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of mortality at 30-days	incidence of mortality	up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedali Riuniti		Foggia	Apulia	71100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

Browse Leaves

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Browse Branches

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