Serum Calprotectin in Surgical Septic Patients

Serum Calprotectin in Surgical Septic Patients as an Early Predictor of Clinical Severity and Mortality: a Prospective Comparative Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Biomarker; Infection, Intraabdominal; Sepsis Abdominal
• Intervention / Treatment: Diagnostic test: serum calprotectin

Detailed Description

Inclusion criteria are age>18 years; diagnosis of upper/lower gastro-intestinal perforation, intestinal occlusion, acute cholecystitis, acute appendicitis or intra-abdominal sepsis.

Enrolled patients will be divided in two groups according to the Calgary PIRO (CPIRO) score evaluation: group A includes patients with CPIRO score </= 2 and represents patient with mild form of intra-abdominal sepsis while group B includes patients with CPIRO score >/= 3, therefore representing patients with more severe systemic forms. The control group (group C) will be made by elective surgical adult patients.

A blood sample will be collected in sample tubes without anticoagulant from all the eligible patients at admission. After centrifugation, the serum will be stored at -80°C until analysis. The serum level of calprotectin will be measured using a commercially available ELISA Kit based on polyclonal antibodies, according to the manufacturer instruction and fully blinded to any clinical data of the patients or controls.

To our knowledge, this is going to be the first study comparing the levels of serum calprotectin in a large cohort of surgical patients with different degree of intra-abdominal sepsis.

Our primary outcome is to determine whether the serum calprotectin level at the admission is increased in septic patients compared to the control group. We will correlate serum calprotectin level with PCT levels, to check which is the most accurate for the detection of sepsis. Our secondary outcome is to analyze if serum calprotectin level at admission correlates with the clinical severity of sepsis, evaluated trough the CPIRO score. Finally, we will verify if calprotectin level at admission is predictive of short and long-term morbidity and mortality, need for ICU admission and invasive/non-invasive post-operative reinterventions.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: SIlvia Strambi, MD; Phone Number: +393334905867; Email: silvia.strambi@phd.unipi.it
• Study Contact Backup: Name: Laura Caponi, MD; Phone Number: +393287852635; Email: laura.caponi@unipi.it

Study Locations

• Italy
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero Universitaria Pisana (AOUP)
    • Contact: Silvia Strambi, MD; Phone Number: +39050996085; Email: silvia.strambi@phd.unipi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Eligible patients with CPIRO 0-2	Diagnostic test: serum calprotectin; A blood sample is collected at time of admission to detect serum level of calprotectin
Group B; Eligible patients with CPIRO >3	Diagnostic test: serum calprotectin; A blood sample is collected at time of admission to detect serum level of calprotectin
Group C; Control group (elective surgical patients without any source of intra-abdominal infection)	Diagnostic test: serum calprotectin; A blood sample is collected at time of admission to detect serum level of calprotectin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Surgical infections; Serum calprotectin
• Additional Relevant MeSH Terms: Infections; Intraabdominal Infections
• Other Study ID Numbers: 11 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No