- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126577
Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis (LIPS)
Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study
When there is infection in the intra-abdominal area, bacteria secrete toxins that are absorbed by the peritoneum. These toxins then bind to lipoproteins (which carry cholesterol in the blood) and are eliminated by the liver. Phospholipid transfer protein (PLTP) is a protein that facilitates the binding of bacterial toxins to lipoproteins and thus their elimination.
The objective of this study is to study the relationship between PLTP and the elimination of bacterial toxins in humans. A better understanding of the elimination of these toxins will lead to a better understanding of the disease. The ultimate objective is to improve the management of intra-abdominal infections.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Bélaid BOUHEMAD
- Phone Number: 03.80.29.30.79
- Email: belaid.bouhemad@chu-dijon.fr
Study Locations
-
-
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Dijon, France, 21000
- Chu Dijon Bourogne
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- person who has given oral consent (patient or family member)
- pre-operative SEPSIS criteria (qSOFA >=2) or vasopressor or mechanical ventilation treatment
- admitted to the operating room for suspected generalized secondary peritonitis
Exclusion Criteria:
- person not affiliated to national health insurance
- person under legal protection (curatorship, guardianship)
- person under court order
- pregnant, parturient or breastfeeding woman
- minor
- immunosuppression (HIV infection, corticosteroid treatment > 0.15 mg/kg/day prednisolone equivalent > 2 weeks, immunosuppressive treatment, primary cellular immune deficiency)
- decision to limit or stop therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with suspected peritonitis
Secondary peritonitis, sepsis and endotoxemia
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4 blood samples of 6 ml each: one before the surgical incision, one after the operation, one 4h after the operation and the last 24h after the operation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative plasma concentration in 3HM
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGUYEN 2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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