NCT04126577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 19, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

October 11, 2019

Last Update Submit

August 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perioperative plasma concentration in 3HM

    24 hours postoperatively

Study Arms (1)

Patients with suspected peritonitis

Secondary peritonitis, sepsis and endotoxemia

Biological: blood samples

Interventions

blood samplesBIOLOGICAL

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.

Patients with suspected peritonitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with secondary peritonitis, sepsis and endotoxemia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

  • Nguyen M, Alvarez M, Berthoud V, Pallot G, Abagri S, Leleu D, Pais-De-Barros JP, Ortega-Deballon P, Guinot PG, Masson D, Gautier T, Bouhemad B. High-density lipoproteins alleviate the endotoxin burden in patients with peritonitis and sepsis: The LIPS study. Eur J Clin Invest. 2025 Dec;55(12):e70099. doi: 10.1111/eci.70099. Epub 2025 Jul 19.

MeSH Terms

Conditions

Peritonitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

December 19, 2019

Primary Completion

October 27, 2022

Study Completion

October 27, 2022

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations