An observational study in Infection, Intraabdominal, Sepsis Abdominal and Biomarker, sponsored by Azienda Ospedaliero, Universitaria Pisana. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Azienda Ospedaliero, Universitaria Pisana · Observational
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Among 13 studies in Intraabdominal Infections with a site in Italy — 1 open to participants now, 1 under way, none of them phase 3. Intraabdominal Infections · Italy.
Among the 13 studies in Intraabdominal Infections with a site in Italy, this one is the only one that started in 2021, is one of 5 observational ones, and was the 13th registered.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
Browse Intraabdominal Infections studies →1 of the 13 studies in Intraabdominal Infections with a site in Italy is open now. Recruiting first, the newest first:
Infectopharm Arzneimittel GmbH · Sites in Italy, Austria, Germany and 2 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 10 Intraabdominal Infections studies recruiting now, 6 (60%) set no upper age limit and 3 (30%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 150 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.
Median enrollment 74 across the 8 interventional studies, 1,000 across the 5 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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6 of 13 have an industry lead sponsor. The 10 most frequent:
Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 57 studies on the registry; 10 are open to participants now.
Azienda Ospedaliero, Universitaria Pisana has 1 study filed under Intraabdominal Infections — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Intraabdominal Infections with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Septic patients requiring surgery at the Department of General and Emergency Surgery of the University of Pisa
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Exclusion Criteria:
Eligible patients with CPIRO 0-2
Diagnostic Test: serum calprotectin
Eligible patients with CPIRO \>3
Diagnostic Test: serum calprotectin
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
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.
Time frame: admission
Plan to share: Undecided
Started Nov 2021 (actual). Primary completion is estimated for Nov 2024, 36 months after the start.
Of 24 observational studies under Intraabdominal Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero, Universitaria Pisana