BridgeMD
Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients
EU CTIS ID: 2024-513526-27-00
What this study is testing
Change in multiple organ failure (MOF) score (determined in the organs lung, heart, kidney, liver, blood) from baseline to day 7 after source control, in the course of peritonitis.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- the patient has a diagnosis of secondary or quaternary peritonitis.
- the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure).
- sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
- the SOFA score is ≥ 8.
- the concentration of IL-6 is ≥ 1000 pg/ml.
- antibiotic therapy is started within 12 h after admission to the intensive care unit.
You likely can't join if
- the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
- the patient is institutionalised by court or regulatory order.
- for female patients only: There is a pregnancy or the patient is breastfeeding.
- the patient is a minor (<18 years).
- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg/dl or creatinine clearance ≤ 30 mL /min /1.73 m²).
- the patient has acute, primarily non-infectious pancreatitis or mediastinitis.
See the full eligibility criteria
- the patient has a diagnosis of secondary or quaternary peritonitis.
- the time of source control is within 6 h of the indication (defined as the date and time of registration for surgery or minimally invasive procedure).
- sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
- the SOFA score is ≥ 8.
- the concentration of IL-6 is ≥ 1000 pg/ml.
- antibiotic therapy is started within 12 h after admission to the intensive care unit.
- the informed consent form has been signed by the patient himself and/or his legal representative (such as his spouse, a proxy with effective power of attorney for health care or a court-appointed guardian) or by a consultant.
- the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
- the patient is institutionalised by court or regulatory order.
- for female patients only: There is a pregnancy or the patient is breastfeeding.
- the patient is a minor (<18 years).
- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg/dl or creatinine clearance ≤ 30 mL /min /1.73 m²).
- the patient has acute, primarily non-infectious pancreatitis or mediastinitis.
- the BMI is > 40.
- the patient has a contraindication to the study medication.
- patient has participated in another drug study within the last 30 days.
- the patient has a dependent or employment relationship with the sponsor or investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.