Could a drug calm the immune storm in severe abdominal infections?

NCT ID NCT07672496

Disease control Sponsor: Fujian Medical University Union Hospital Source: ClinicalTrials.gov ↗

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests whether ulinastatin, a drug that reduces inflammation, can help patients with severe abdominal infections. The infection often causes the immune system to overreact, leading to organ failure and high risk of death. Researchers will give patients either a low or high dose of ulinastatin or a placebo for five days, alongside standard care, and measure changes in immune and inflammatory markers. The goal is to see if ulinastatin can restore immune balance and improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ulinastatin
What this could lead to: If ulinastatin improves immune function and reduces inflammation, it could lead to a new treatment for severe abdominal infections and lower the risk of organ failure or death.
What could go wrong: This is a small, early pilot study, so results may not be conclusive. The drug may not show benefit, and there are always risks of side effects or allergic reactions.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to provide written informed consent voluntarily. 2. Age ≥ 18 years old, any gender. 3. Diagnosed with severe complicated intra-abdominal infection (cIAI) within 48 hours, consistent with the 2025 expert consensus for cIAI diagnosis. Diagnosis is confirmed by clinical symptoms (fever, abdominal pain, distension, etc.), abdominal imaging (CT/ultrasound/MRI), intraoperative findings, or positive pathogen culture of abdominal drainage fluid. 4. Baseline Sequential Organ Failure Assessment (SOFA) score ≥ 2 points. Exclusion Criteria: 1. Severe immune deficiency conditions, including AIDS, prior solid organ or bone marrow transplantation, HIV infection with CD4 count \< 200 cells/mm³, long-term high-dose glucocorticoid therapy (prednisone \> 20 mg/day), ongoing chemotherapy for malignant tumors, or absolute neutrophil count \< 1000 cells/mm³. 2. Severe irreversible underlying diseases, including chronic renal failure requiring dialysis, Child-Pugh grade C liver disease, liver disease with severe portal hypertension, or acute liver failure. 3. Patients with active malignant tumors, pregnancy, or severe psychiatric disorders. 4. American Society of Anesthesiologists (ASA) physical status grade IV or above. 5. Severe coagulation disorder defined as ISTH-DIC score ≥ 5 points. 6. Critically ill patients with expected death within 48 hours after admission. 7. Known allergy to ulinastatin or any ingredients of the study preparation. 8. Any condition that, in the judgment of the principal investigator, makes the patient inappropriate for trial participation.

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Conditions

The condition(s) this trial relates to.

immune system disorder infectious disease with sepsis infectious peritonitis Inflammation Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complicated intra-abdominal infection (CIAI) Immune dysfunction Sepsis Systemic inflammatory response

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a drug calm the immune storm in severe abdominal infections?

What the study statuses mean