An observational study in Acute Mesenteric Ischemia, Sepsis Bacterial and Intra-abdominal Infection, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Central Hospital, Nancy, France · Observational
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Among 20 studies in Intraabdominal Infections with a site in France — 1 open to participants now, 1 under way, none of them phase 3. Intraabdominal Infections · France.
Among the 20 studies in Intraabdominal Infections with a site in France, this one is the only one that started in 2024, is one of 9 observational ones, and was the 17th registered.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
Browse Intraabdominal Infections studies →1 of the 20 studies in Intraabdominal Infections with a site in France is open now. Recruiting first, the newest first:
Central Hospital, Nancy, France · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
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 to 90 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 174 across 48 observational studies indexed under Intraabdominal Infections.
Median enrollment 204 across the 11 interventional studies, 200 across the 9 observational. Of the 18 that completed or were terminated, 7 (39%) have results posted.
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11 of 20 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 5 studies 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 20 studies in Intraabdominal Infections with a site in France, from their registry updates:
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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
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.
Adult patient with suspected of confirmed acute mesenteric ischemia who required urgent surgery for revascularisation and/or intra-abdominal infection
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Exclusion Criteria:
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
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
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® 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.
Presence or absence of bacterial coinfection during acute mesenteric ischemia
Septicyte Lab test \< 4 if there is no infection
Time frame: Day 0 (pre operative)
Diagnostic performance of Septicyte Lab test to rule out the presence of intra-abdominal infection during acute mesenteric ischemia
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the Septicyte Lab test
Time frame: Day 0 (pre operative)
Diagnostic performance of PCT to rule out the presence of intra-abdominal infection during acute mesenteric ischemia
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the PCT
Time frame: Day 0 (pre operative)
Diagnostic performance of CRP to rule out the presence of intra-abdominal infection during acute mesenteric ischemia
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value of the CRP
Time frame: 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
Value of Septicyte Lab test
Time frame: Day 1
Plan to share: No
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Ran from Aug 2024 to primary completion in Sep 2024, 1 month.
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 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →