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SepsisMASSIVENCT07910786

MetAbolic Changes in the SepSis LIVEr

A study testing Liver biopsy and blood sampling in people with Sepsis and Peritonitis; Acute, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the activity status of two highly essential transcription factors (GR and PPARa), which are of crucial importance in the successful metabolic rearrangements (gluconeogenesis and fatty acid beta oxidation respectively) during sepsis, but which appear to lose their activity in a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Peritonitis; Acute
What is being tested?
Liver biopsy and blood sampling
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteBelgium
Study dates
1 Jun 2023to 31 Jan 2026
Phase
Interventional
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

Who may be able to join

  • Inclusion criteria for patients with peritonitis (all should be present):
  • Age ≥18
  • Patient with suspected or confirmed complicated intra-abdominal infection for which a surgical procedure is planned and during which at least one of the following is confirmed:
  • Gross peritoneal inflammation with purulent exudates (ie, peritonitis).
  • Intra-abdominal abscess.
  • Macroscopic intestinal perforation with localized or diffuse peritonitis. e.g. due to intestinal perforation (stomach, bowel, gallbladder, appendicitis, traumatic, postoperatively) or intestinal arterial occlusion or bowel obstruction/ileus.
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  • Presence of acute organ dysfunction caused by the infection determined by deviation in at least one of the following organ systems:
  • Respiration: PaO2/Fio2 ≤ 300 mm Hg
  • Coagulation: Platelets ≤ 100x103/μl
  • Liver: Bilirubin ≥ 2 mg/dl
  • Cardiovascular: Vasopressors required (dopamine, dobutamine, epinephrine or norepinephrine: any dose)
  • Central nervous system: Glasgow coma scale score ≤ 12
  • Renal: Creatinine > 2 mg/dl
  • Written informed consent from the patient or his/her legal representative.
  • Inclusion criteria for elective surgery patients:
  • Age ≥18
  • Patient should be scheduled for elective major gastrointestinal surgery
  • Written informed consent

Who cannot join

  • Exclusion criteria for patients with peritonitis:
  • Age < 18 years
  • Pregnancy
  • Known HIV, Hepatitis B or C
  • Clinically significant coagulopathy as assessed by the investigator
  • Use of immunosuppressant treatment or in chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone can be included
Show all 19Show fewer
  • Acute liver disease (determined by the treating physician) or chronic liver disease (child pugh A,B,C)
  • Chronic insulin dependent diabetes mellitus
  • No informed consent obtained
  • Exclusion criteria for elective surgery patients:
  • Age < 18 years
  • Pregnancy
  • Known HIV, Hepatitis B or C
  • Clinically significant coagulopathy as assessed by the investigator
  • Use of immunosuppressant treatment or in chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients
  • Acute or chronic liver disease, diabetes mellitus, dyslipidemia, liver steatosis (macroscopically diagnosed during surgery)
  • Signs or symptoms of infection as assessed by the investigator
  • Chronic insulin dependent diabetes mellitus
  • No informed consent obtained

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital, Ghent

    Ghent, 9000

Other trials in Belgium

About this study

The aim of this study is to evaluate the activity status of two highly essential transcription factors (GR and PPARa), which are of crucial importance in the successful metabolic rearrangements (gluconeogenesis and fatty acid beta oxidation respectively) during sepsis, but which appear to lose their activity in a mouse model of septic peritonitis. Since these metabolic activities are located in liver, the activity status of these factors will be studied in livers of septic peritonitis patients and control patients, and will be related to metabolites in blood and to the disease status of these patients.

Being tested
Liver biopsy, blood sampling
Keywords
sepsis, glucocorticoid receptor, liver, Peroxisome Proliferator-Activated Receptor Alpha (PPARa), metabolism, peritonitis
Medical subject headings
Sepsis, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver biopsyProcedure or surgery

    > Liver biopsies (2 pieces of 5mm x 5mm x 5mm) will be collected during surgery

  • blood samplingProcedure or surgery

    > Blood draw via arterial or venous line: 1 EDTA tube (10 ml) will be collected during surgery, as well as on postoperative day 1, 2, 3, 5 and 7.

Study groups in NCT07910786
Study groupRoleWhat they receive
Elective surgery patients (Control)Placebo comparatorPatient is scheduled for elective major gastrointestinal surgery
Receives: Procedure: Liver biopsy; Procedure: blood sampling
PeritonitisActive comparatorPatient with suspected or confirmed complicated intra-abdominal infection for which a surgical procedure is planned
Receives: Procedure: Liver biopsy; Procedure: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To study whether septic peritonitis patients have alterations in the expression levels of inflammatory genes linked to reduced activity of GR and PPARa in liver tissue.

    Evaluation of the expression levels of inflammatory genes linked to a reduced GR and PPARa activity. Compare these gene expressions with control livers.

    Measured: Day 0

  2. To study whether human sepsis liver samples show an accumulation of FFA and alterations in collagen in liver.

    Lipid and collagen staining in liver samples. This will be done with an immunostaining with Lipidtox (Life Technologies) and Picrosirius Red/Masson Trichrome.

    Measured: Day 0

  3. To study whether there are indications for reduced activity of GR and PPARa in blood plasma.

    Metabolites measurements in plasma (glucose/lactate/glycerol/FFA). These blood parameters can be indicative for GR and PPARa activity in the liver.

    Measured: up to day 7

  4. To study whether there is a correlation between reduced GR/PPARa activity in the liver during sepsis and the general status of the septic patient (SOFA score), inflammatory markers such as IL6, TNF, procalcitonin, corticosterone or other metabolites.

    Inflammation markers (corticosterone, IL6, TNF, procalcitonin) and other metabolites in plasma, as well as SOFA score will be linked with GR/PPARa functioning in the liver.

    Measured: up to day 30

  5. To study whether septic peritonitis patients have alterations in the expression levels of metabolic genes linked to reduced activity of GR and PPARa in liver tissue.

    Evaluation of the expression levels of inflammatory genes and metabolic genes linked to a reduced GR and PPARa activity. Compare these gene expressions with control livers.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study start1 Jun 2023
  3. Primary completion31 Jan 2026
  4. Study completion31 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07910786
Sponsor's protocol ID
ONZ-2022-0520
Other IDs
1220924N, S003122N
Acronym
MASSIVE
Status last verified
Oct 2026
First submitted
5 Jun 2025
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared with participating centers only. Data provided by the local investigators are primarily the property of the ICU that collected the data. Local investigators shall have access to their data after they have been entered in the central database.

Publications

  • Halimi F, Vanderhaeghen T, Timmermans S, Croubels S, Libert C, Vandewalle J. Comparative Analysis of Hepatic Gene Expression Profiles in Murine and Porcine Sepsis Models. Int J Mol Sci. 2024 Oct 15;25(20):11079. doi: 10.3390/ijms252011079.

    PubMed 39456859

  • Vandewalle J, Timmermans S, Paakinaho V, Vancraeynest L, Dewyse L, Vanderhaeghen T, Wallaeys C, Van Wyngene L, Van Looveren K, Nuyttens L, Eggermont M, Dewaele S, Velho TR, Moita LF, Weis S, Sponholz C, van Grunsven LA, Dewerchin M, Carmeliet P, De Bosscher K, Van de Voorde J, Palvimo JJ, Libert C. Combined glucocorticoid resistance and hyperlactatemia contributes to lethal shock in sepsis. Cell Metab. 2021 Sep 7;33(9):1763-1776.e5. doi: 10.1016/j.cmet.2021.07.002. Epub 2021 Jul 23.

    PubMed 34302744

  • Vandewalle J, Libert C. Sepsis: a failing starvation response. Trends Endocrinol Metab. 2022 Apr;33(4):292-304. doi: 10.1016/j.tem.2022.01.006. Epub 2022 Feb 15.

    PubMed 35181202

  • Van Dender C, Timmermans S, Paakinaho V, Vanderhaeghen T, Vandewalle J, Claes M, Garcia B, Roman B, De Waele J, Croubels S, De Bosscher K, Meuleman P, Herpain A, Palvimo JJ, Libert C. A critical role for HNF4alpha in polymicrobial sepsis-associated metabolic reprogramming and death. EMBO Mol Med. 2024 Oct;16(10):2485-2515. doi: 10.1038/s44321-024-00130-1. Epub 2024 Sep 11.

    PubMed 39261648

  • Van Wyngene L, Vanderhaeghen T, Timmermans S, Vandewalle J, Van Looveren K, Souffriau J, Wallaeys C, Eggermont M, Ernst S, Van Hamme E, Goncalves A, Eelen G, Remmerie A, Scott CL, Rombouts C, Vanhaecke L, De Bus L, Decruyenaere J, Carmeliet P, Libert C. Hepatic PPARalpha function and lipid metabolic pathways are dysregulated in polymicrobial sepsis. EMBO Mol Med. 2020 Feb 7;12(2):e11319. doi: 10.15252/emmm.201911319. Epub 2020 Jan 9.

    PubMed 31916705

  • Vandewalle J, Garcia B, Timmermans S, Vanderhaeghen T, Van Wyngene L, Eggermont M, Dufoor H, Van Dender C, Halimi F, Croubels S, Herpain A, Libert C. Hepatic Peroxisome Proliferator-Activated Receptor Alpha Dysfunction in Porcine Septic Shock. Cells. 2022 Dec 16;11(24):4080. doi: 10.3390/cells11244080.

    PubMed 36552845

  • Van Wyngene L, Vandewalle J, Libert C. Reprogramming of basic metabolic pathways in microbial sepsis: therapeutic targets at last? EMBO Mol Med. 2018 Aug;10(8):e8712. doi: 10.15252/emmm.201708712.

    PubMed 29976786

Questions about this trial

What is this clinical trial studying?

A study testing Liver biopsy and blood sampling in people with Sepsis and Peritonitis; Acute, run by University Hospital, Ghent at 1 site in Belgium.

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 18 inclusion and 19 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 2 Nov 2026. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?

To study whether septic peritonitis patients have alterations in the expression levels of inflammatory genes linked to reduced activity of GR and PPARa in liver tissue. (time frame: Day 0). The study lists 5 primary outcomes in all. 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 NCT07910786, which also lists 7 linked publications.

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 2 Nov 2026.

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