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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04126577

Collaborator

(none)

Enrollment

Location

37.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis	Biological: blood samples

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 19, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with suspected peritonitis Secondary peritonitis, sepsis and endotoxemia	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.

Arm

Intervention/Treatment

Patients with suspected peritonitis

Secondary peritonitis, sepsis and endotoxemia

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.

Outcome Measures

Primary Outcome Measures

Perioperative plasma concentration in 3HM [24 hours postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France	21000

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT04126577

Other Study ID Numbers:

NGUYEN 2019

First Posted:

Oct 15, 2019

Last Update Posted:

Apr 10, 2020

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peritonitis

Study Results

No Results Posted as of Apr 10, 2020