NCT06180265

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

3.5 years

First QC Date

July 25, 2023

Last Update Submit

December 21, 2023

Conditions

Septic Shock

Keywords

septic shock

Outcome Measures

Primary Outcomes (1)

  • incidence of mortality at 30-days

    incidence of mortality

    up to 30 days

Study Arms (1)

septic shock patients

OTHER

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

Diagnostic Test: presepsin, procalciton, endotoxin

Interventions

presepsin, procalciton, endotoxinDIAGNOSTIC_TEST

measurement of presepsin, procalciton, endotoxin plasmatic levels

septic shock patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caucasian patients
  • patients undergoing laparoscopic major abdominal surgery

You may not qualify if:

  • pregnancy,
  • organ transplantation,
  • palliative care
  • metastatic cancer
  • head trauma and polytrauma
  • coagulopathies
  • use of anticoagulants
  • neurological disease
  • autoimmune disease
  • thyroid disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2023

First Posted

December 22, 2023

Study Start

February 1, 2020

Primary Completion

July 19, 2023

Study Completion

July 19, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

IT(1)