Serum Calprotectin in Surgical Septic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: serum calprotectin.
- Who it may be relevant to
- Registry conditions: Infection, Intraabdominal, Sepsis Abdominal, Biomarker. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serum Calprotectin in Surgical Septic Patients as an Early Predictor of Clinical Severity and Mortality: a Prospective Comparative Study.
Overview
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.
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.
Interventions
- Diagnostic test serum calprotectin
A blood sample is collected at time of admission to detect serum level of calprotectin
Primary outcome measures
- Sepsis detection [Time frame: admission]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Azienda Ospedaliero Universitaria Pisana (AOUP) — Pisa
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. PMID 27414210
- 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
Identifiers
NCT: NCT06614088 · 11 2021