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Study on the Effects of Immunoglobulin A, G, and M in Patients with Peritonitis and Sepsis After Infection Control

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Pentaglobin in patients with peritonitis and sepsis. Peritonitis is an inflammation of the lining of the abdomen, often due to infection, while sepsis is a serious condition that occurs when the body's response to infection causes injury to its own tissues and organs. The treatment being tested, Pentaglobin, is a solution containing immunoglobulins, which are proteins that help the immune system fight infections. The study aims to understand how this treatment can help improve the condition of patients who have undergone procedures to control the source of infection.

Participants in the study will receive the treatment through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will monitor changes in the health of several organs, including the lungs, heart, kidneys, liver, and blood, over a period of seven days after the infection source has been controlled. The goal is to see if Pentaglobin can help reduce the severity of multiple organ failure, a condition where several organs stop working properly, which can occur in severe cases of peritonitis and sepsis.

The study will also track other important outcomes, such as survival rates within 28 and 90 days, and changes in the severity of organ failure by the fifth day of treatment. By understanding these effects, researchers hope to determine the potential benefits of using Pentaglobin in treating these serious conditions. The study is designed to provide valuable insights into personalized medicine approaches for patients with peritonitis and sepsis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, the patient undergoes an initial assessment to confirm eligibility. This includes verifying a diagnosis of secondary or quaternary peritonitis and the presence of sepsis or septic shock.

    The assessment also checks if the SOFA score is 8 or higher and if the IL-6 concentration is 1000 pg/ml or more. The SOFA score is a measure used to track a patient's status during their stay in an intensive care unit.

  2. Step 2

    Source control procedure

    A procedure to control the source of infection is performed within 6 hours of the indication. This could be surgery or a minimally invasive procedure.

  3. Step 3

    Initiation of antibiotic therapy

    Antibiotic therapy is started within 12 hours after admission to the intensive care unit to manage the infection.

  4. Step 4

    Administration of pentaglobin

    The patient receives Pentaglobin, a solution for infusion containing immunoglobulins A, G, and M. This is administered intravenously.

    The dosage and frequency of administration are determined by the study protocol and the patient's specific needs.

  5. Step 5

    Monitoring and evaluation

    The patient's multiple organ failure (MOF) score is monitored from baseline to day 7 after the source control procedure. This score assesses the function of the lungs, heart, kidneys, liver, and blood.

    Secondary evaluations include monitoring for death within 28 and 90 days, changes in the MOF score from baseline to day 5, and the presence of multi-organ failure on day 7.

Who can join the trial?

7 criteria

  • The patient must have a diagnosis of secondary or quaternary peritonitis. This means an infection in the abdomen that has spread from another area.
  • The procedure to control the source of infection must be done within 6 hours of the decision to perform it. This is the time from when the surgery or procedure is scheduled.
  • The patient must have sepsis or septic shock. Sepsis is a serious condition where the body responds to an infection in a harmful way.
  • The SOFA score must be 8 or higher. The SOFA score is a way to measure how well the body's organs are working.
  • The level of IL-6 in the blood must be 1000 pg/ml or higher. IL-6 is a substance in the body that can increase during inflammation or infection.
  • Antibiotic treatment must start within 12 hours after the patient is admitted to the intensive care unit.
  • The patient or their legal representative must sign the informed consent form. This means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

2 criteria

  • Patients with **secondary or quaternary peritonitis** cannot participate. This means if you have an infection in the lining of your abdomen that is not the first occurrence, you are not eligible.
  • Patients with **sepsis** are excluded. Sepsis is a serious condition where the body has a severe response to an infection, affecting the whole body.
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Investigated drugs

Pentaglobin is a medication used in this clinical trial. It is an immunoglobulin preparation that is administered to patients who have undergone a procedure to control an infection source in the abdomen, specifically in cases of peritonitis. The goal of using Pentaglobin in this study is to help improve the function of multiple organs, such as the lungs, heart, kidneys, liver, and blood, by reducing the severity of organ failure over a period of seven days after the infection source has been controlled.

What is already known about the treatment

Pentaglobin – This medication is administered intravenously and is used in the treatment of secondary or quaternary peritonitis and sepsis. It is currently being studied in clinical trials to assess its effectiveness in improving organ function in patients with peritonitis. Pentaglobin is an immunoglobulin preparation that works by enhancing the immune response to fight infections. It is classified as an immunoglobulin therapy and is used to support the immune system in severe infections.

Investigated diseases

  • Secondary Peritonitis

    This condition occurs when the lining of the abdominal cavity, known as the peritoneum, becomes inflamed due to an infection that spreads from another part of the body. It often results from a rupture in the abdominal organs, such as the appendix or intestines, leading to the leakage of bacteria or other harmful substances into the peritoneal cavity. The inflammation can cause severe abdominal pain, tenderness, and swelling. As the condition progresses, it may lead to the formation of abscesses and can affect the function of nearby organs. If not managed, the infection can spread, leading to more severe complications.

  • Sepsis

    This is a serious medical condition that arises when the body's response to an infection causes widespread inflammation. It can begin with an infection in any part of the body, such as the lungs, urinary tract, or skin, and can lead to systemic inflammation. As sepsis progresses, it can cause a drop in blood pressure, leading to poor blood flow to vital organs. This can result in organ dysfunction or failure if not addressed promptly. The condition can escalate quickly, requiring immediate medical attention to prevent further complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513526-27-00Protocol code15-167Estimated enrolment200 patientsSponsorUniversitaetsklinikum Aachen AöR

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