Evaluating serum calprotectin levels in patients with intra-abdominal sepsis
Serum Calprotectin in Surgical Septic Patients as an Early Predictor of Clinical Severity and Mortality: a Prospective Comparative Study.
This study is testing if measuring calprotectin levels in the blood can help doctors understand how severe intra-abdominal sepsis is in patients who need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana Academic / other |
| Locations | 1 site (Pisa) |
| Trial ID | NCT06614088 on ClinicalTrials.gov |
What this trial studies
This study aims to assess serum calprotectin levels in patients suffering from intra-abdominal sepsis who require surgical treatment. Patients will be categorized based on the Calgary PIRO score to differentiate between mild and severe forms of sepsis. Blood samples will be collected at admission and analyzed to determine if calprotectin levels correlate with disease severity and patient outcomes. The goal is to establish calprotectin as a rapid and reliable biomarker for diagnosing sepsis in surgical patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific diagnoses such as gastrointestinal perforation, intestinal occlusion, or intra-abdominal sepsis.
Not a fit: Patients who have had recent surgery or trauma, or those diagnosed with acute pancreatitis or burns may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for early diagnosis and severity assessment of intra-abdominal sepsis, potentially improving patient outcomes.
How similar studies have performed: This approach is novel, as it aims to be the first large-scale comparison of serum calprotectin levels in surgical patients with varying degrees of intra-abdominal sepsis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pisa
- Azienda Ospedaliero Universitaria Pisana (AOUP) — Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: SIlvia Strambi, MD
- Email: silvia.strambi@phd.unipi.it
- Phone: +393334905867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.