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NCT Number: NCT06180265

The Diagnostic and Prognostic Value of Presepsin in Sepsis

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).

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti

Foggia, Apulia, 71100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

presepsin, procalciton, endotoxin

Diagnostic Test

measurement of presepsin, procalciton, endotoxin plasmatic levels

Primary outcomes

  1. incidence of mortality at 30-days

    Time frame: up to 30 days

    incidence of mortality

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2023
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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