Serum Calprotectin in Surgical Septic Patients

NCT06614088 | Recruiting

• 1 other identifier: 11 2021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To early evaluate the serum levels of calprotectin in patients suffering from intra-abdominal sepsis requiring a surgical treatment. The research project aims to investigate the role of serum calprotectin in the diagnosis of sepsis and to establish whether its level significantly correlates with different degree of disease severity and with short and long-term outcomes. If these associations were confirmed, serum calprotectin would represent an easily and rapidly detectable biomarker able to predict the severity of sepsis.

Conditions

Infection, Intraabdominal; Sepsis Abdominal; Biomarker

Keywords

Serum calprotectin; Surgical infections

Outcome Measures

Primary Outcomes (1)

• Sepsis detection

  We'll measure the serum calprotectin level in enrolled patients of the two groups (group A and B) and in patients of the control group.

  admission

Study Arms (3)

Group A

Eligible patients with CPIRO 0-2

Diagnostic Test: serum calprotectin

Group B

Eligible patients with CPIRO \>3

Diagnostic Test: serum calprotectin

Group C

Control group (elective surgical patients without any source of intra-abdominal infection)

Diagnostic Test: serum calprotectin

Interventions

serum calprotectin DIAGNOSTIC_TEST

A blood sample is collected at time of admission to detect serum level of calprotectin

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Septic patients requiring surgery at the Department of General and Emergency Surgery of the University of Pisa

You may qualify if:

• diagnosis of upper/lower gastro-intestinal perforation
• diagnosis of intestinal occlusion
• diagnosis of acute cholecystitis
• diagnosis of complicated acute appendicitis
• radiological diagnosis of intra-abdominal sepsis

You may not qualify if:

• recent (\<3 months) surgery
• recent (\<3 months) trauma
• diagnosis of acute pancreatitis
• diagnosis of burn

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Pisana (AOUP)

Pisa, 56126, Italy

RECRUITING

Related Publications (2)

• Simm M, Soderberg E, Larsson A, Castegren M, Nilsen T, Eriksson M, Lipcsey M. Performance of plasma calprotectin as a biomarker of early sepsis: a pilot study. Biomark Med. 2016 Aug;10(8):811-8. doi: 10.2217/bmm-2016-0032. Epub 2016 Jul 14.

  PMID: 27414210 BACKGROUND

• Larsson A, Tyden J, Johansson J, Lipcsey M, Bergquist M, Kultima K, Mandic-Havelka A. Calprotectin is superior to procalcitonin as a sepsis marker and predictor of 30-day mortality in intensive care patients. Scand J Clin Lab Invest. 2020 Feb-Apr;80(2):156-161. doi: 10.1080/00365513.2019.1703216. Epub 2019 Dec 14.

  PMID: 31841042 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

SIlvia Strambi, MD

CONTACT

+393334905867; silvia.strambi@phd.unipi.it

Laura Caponi, MD

CONTACT

+393287852635; laura.caponi@unipi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 26, 2024
• Study Start: November 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

IT (1)