Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia

NCT06507423 | Completed FDA Device

• 1 other identifier: NOVY_2024_PI_090
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help determine whether the SeptiCyte LAB test can accurately differentiate between SIRS and actual infections in postoperative patients, potentially reducing unnecessary antibiotic use and improving patient outcomes in cases of acute mesenteric ischemia

Conditions

Acute Mesenteric Ischemia; Sepsis Bacterial; Intra-abdominal Infection; Digestive Inflammation

Keywords

acute mesenteric schema; sepsis; septicyte; antimicrobial stewardship; intra-abdominal infection; aortic vascular surgery; surgical aortic clamping

Outcome Measures

Primary Outcomes (1)

• Presence or absence of bacterial coinfection during acute mesenteric ischemia

  Septicyte Lab test \< 4 if there is no infection

  Day 0 (pre operative)

Secondary Outcomes (4)

• Diagnostic performance of Septicyte Lab test to rule out the presence of intra-abdominal infection during acute mesenteric ischemia

  Day 0 (pre operative)

• Diagnostic performance of PCT to rule out the presence of intra-abdominal infection during acute mesenteric ischemia

  Day 0 (pre operative)

• Diagnostic performance of CRP to rule out the presence of intra-abdominal infection during acute mesenteric ischemia

  Day 0 (pre operative)

• Change in Septicyte Lab test during the post-operative period to address the influence of surgery on the response of patient's immune system

  Day 1

Study Arms (2)

Control group

The control group will consist of adult patients undergoing open vascular surgery for the treatment of an aortic aneurysm. This procedure requires surgical aortic clamping of variable duration, which may lead to potential ischemic events in the digestive system

Device: Septicyte Lab Test pre operative; Device: Septicyte Lab Test post operative

Case

The "case" group consist of adult patients suffering from acute mesenteric ischemia who required urgent surgery

Device: Septicyte Lab Test pre operative; Device: Septicyte Lab Test post operative

Interventions

Septicyte Lab Test pre operative DEVICE

SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.

Case; Control group

Septicyte Lab Test post operative DEVICE

SeptiCyte® technology uses proprietary biomarker signatures to assess the response of a patient's immune system to infections. It provides a score which can be used to differentiate sepsis from systemic inflammatory response. Each included patient will received the Septicyte LAB test before and after surgery for acute mesenteric ischemia suspicion. The results will be compared to standard of care, retrospectively.

Case; Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with suspected of confirmed acute mesenteric ischemia who required urgent surgery for revascularisation and/or intra-abdominal infection

You may qualify if:

• Patient aged over 18 years
• Affiliated to health assurance system
• Hospitalized in the ICU for confirmed mesenteric ischemia\* for less than 24 hours with an indication for laparotomy
• Hospitalized in the ICU for confirmed mesenteric ischemia\* who underwent laparotomy for revascularization or digestive resection less than 24 hours ago
• Intraoperative bacteriological samples and blood cultures performed within 24 hours of medical management

You may not qualify if:

• decline to participate
• no consent available

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, Lorraine, 54500, France

Location

MeSH Terms

Conditions

Intraabdominal Infections; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)