PeritonitisLIPSNCT04126577
Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis
An observational study of Peritonitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis
- What is being tested?
- blood samples
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2019to 27 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with secondary peritonitis, sepsis and endotoxemia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Peritonitis
- Being tested
- blood samples
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected peritonitis | Secondary peritonitis, sepsis and endotoxemia Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative plasma concentration in 3HM
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start19 Dec 2019
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126577
- Sponsor's protocol ID
- NGUYEN 2019
- Acronym
- LIPS
- Status last verified
- Aug 2023
- First submitted
- 11 Oct 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40682387
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04126577
- Acronym / sponsor ID
- LIPS / NGUYEN 2019
- Conditions
- Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected peritonitis | – | Biological: blood samplesSecondary peritonitis, sepsis and endotoxemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with secondary peritonitis, sepsis and endotoxemia
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- person not affiliated to national health insurance
- person under legal protection (curatorship, guardianship)
- person under court order
- pregnant, parturient or breastfeeding woman
- minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples4 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. | Biological | Patients with suspected peritonitis |
Primary outcome
Perioperative plasma concentration in 3HM
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 40682387Nguyen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative plasma concentration in 3HM (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.