An interventional study of Liver biopsy and blood sampling in Sepsis and Peritonitis; Acute, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 23 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Inclusion criteria for patients with peritonitis (all should be present):
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:
Presence of acute organ dysfunction caused by the infection determined by deviation in at least one of the following organ systems:
B. Inclusion criteria for elective surgery patients:
Exclusion Criteria:
A. Exclusion criteria for patients with peritonitis:
B. Exclusion criteria for elective surgery patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient is scheduled for elective major gastrointestinal surgery
Procedure: Liver biopsy · Procedure: blood sampling
Patient with suspected or confirmed complicated intra-abdominal infection for which a surgical procedure is planned
Procedure: Liver biopsy · Procedure: blood sampling
\> Liver biopsies (2 pieces of 5mm x 5mm x 5mm) will be collected during 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.
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: up to day 7
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.
Time frame: up to day 30
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.
Time frame: Day 0
Plan to share: 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.
Ran from Jun 2023 to primary completion in Jan 2026, 31 months.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 31 months is above that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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