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Completed

NCT Number: NCT06507423

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

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy

Nancy, Lorraine, 54500, France

About this study

Introduction Early diagnosis of bacterial infections is crucial in intensive care, as conditions such as sepsis and septic shock are emergencies with high mortality rates. Conversely, Systemic Inflammatory Response Syndrome (SIRS) is a deregulated response to an insult without an infectious origin. SIRS is common post-major surgery and complicates the diagnosis between a simple inflammatory response and an actual infection. Although antibiotic therapy is undisputed in septic shock, the rise of antibiotic resistance and the lack of new antibiotics demand a judicious and well-argued prescription in probable sepsis cases. Rapid diagnostics are essential to identify patients who will benefit from empirical antibiotic therapy.

Current Diagnostic Challenges Microbiological documentation remains the gold standard for confirming sepsis or septic shock. However, the delay in obtaining standard bacteriology results poses a risk to patient survival. Biomarkers like CRP and PCT have been proposed for sepsis diagnosis, but their reliability is limited by numerous confounding factors, making them less specific.

The SeptiCyte LAB Test Recent advances in sequencing technology have made molecular biology techniques more accessible and rapid. SeptiCyte LAB is a molecular test based on the quantitative sequencing of mRNA from four genes (CEACAM4, LAMP1, PLA2G7, and PLAC8) involved in bacterial infection signaling. Studies have shown a specificity of 94% and a negative predictive value of 98.8% in ICU patients suspected of sepsis, with a threshold value above 4. These results have also been confirmed in elective esophageal surgery populations, demonstrating encouraging statistical performance.

Relevance to Acute Mesenteric Ischemia (AMI) AMI is a rare and difficult-to-diagnose condition with high diagnostic delays and mortality rates. Its initial presentation often mimics sepsis or septic shock, leading to the early administration of broad-spectrum empirical antibiotics due to fears of bacterial translocation or perforation. Although surgical guidelines encourage systemic antibiotic use, there is insufficient evidence for its routine application.

Study Objective While data on the SeptiCyte LAB test is available for cardiac and digestive surgeries, there is none for vascular surgery. This study aims to evaluate the SeptiCyte LAB test's ability to identify postoperative SIRS patients to reduce empirical antibiotic use while awaiting standard bacteriology results and to assess the impact of surgery on the SeptiCyte LAB test. We will study patients admitted to intensive care units pre- and post-open laparotomy for the treatment of embolic or thrombotic AMI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • decline to participate
  • no consent available

Treatment and study plan

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.

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.

Primary outcomes

  1. Presence or absence of bacterial coinfection during acute mesenteric ischemia

    Time frame: Day 0 (pre operative)

    Septicyte Lab test < 4 if there is no infection

Secondary outcomes

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

    Time frame: Day 0 (pre operative)

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the Septicyte Lab test

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

    Time frame: Day 0 (pre operative)

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the PCT

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

    Time frame: Day 0 (pre operative)

    Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the CRP

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

    Time frame: Day 1

    Value of Septicyte Lab test

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: SPASM

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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