Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614088
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-08-11
Brief Title:
Serum Calprotectin in Surgical Septic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Serum Calprotectin in Surgical Septic Patients as an Early Predictor of Clinical Severity and Mortality a Prospective Comparative Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Inclusion criteria are age18 years diagnosis of upperlower 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 -80C 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 invasivenon-invasive post-operative reinterventions
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 -80C 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 invasivenon-invasive post-operative reinterventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None