Azienda Ospedaliero Universitaria Pisana (AOUP)
Pisa, 56126, Italy
Location status: Recruiting
NCT Number: NCT06614088
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Pisa, 56126, Italy
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A blood sample is collected at time of admission to detect serum level of calprotectin
Time frame: admission
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.
Contact information is provided by the study sponsor or research team.
Laura Caponi, MD
CONTACT
SIlvia Strambi, MD
CONTACT
Azienda Ospedaliero, Universitaria Pisana
Other
Serum Calprotectin in Surgical Septic Patients as an Early Predictor of Clinical Severity and Mortality: a Prospective Comparative Study.
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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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