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NCT04126577 Clinical Trial

Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis

Peritonitis Clinical Trial

— LIPS  

Official title:
Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04126577
Other study ID # NGUYEN 2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 19, 2019
Est. completion date October 27, 2022

Study information
Verified date August 2023
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date October 27, 2022
Est. primary completion date October 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• blood samples
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.

Locations
Country Name City State
France Chu Dijon Bourogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative plasma concentration in 3HM 24 hours postoperatively
See also
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Active, not recruiting NCT02755610 - Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis N/A
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Completed NCT02926846 - IV Antibiotics With Lavage for Severe PD Peritonitis Phase 4