Prospective, randomized study concerning personalized medicine with Pentaglobin® after interventional infectious source control in peritonitis patients
- Conditions
- Investigation of Pentaglobin® therapy in patients with sepsis and/or septic shock triggered by peritonitis after surgical infectious source control and simultaneous administration of antibiotics.MedDRA version: 21.1Level: LLTClassification code 10081559Term: Septic peritonitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2016-001788-34-DE
- Lead Sponsor
- niversity Hospital Aachen, AöR, Dean of the Medical Faculty of the RWTH Aachen for the Managing Board of the University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. the patient has a diagnosis of secondary or quaternary peritonitis.
2. 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).
3. sepsis and/or septic shock (according to the current sepsis guideline of the German Sepsis Society) are present.
4. the SOFA score is = 8.
5. the concentration of IL-6 is = 1000 pg/ml.
6. antibiotic therapy is started within 12 h after admission to the intensive care unit.
7. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1. the patient has a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis, sepsis and/or septic shock.
2. for female patients only: There is a pregnancy or the patient is breastfeeding.
3. the patient is a minor (<18 years).
4. The patient has known chronic renal dysfunction requiring dialysis (creatinine = 3.4 mg/dl or creatinine clearance = 30 mL /min /1.73 m2).
5. the patient has acute, primarily non-infectious pancreatitis or mediastinitis.
6. the BMI is > 40.
7. the patient has a contraindication to the study medication.
8. patient has participated in another drug study within the last 30 days.
9. the patient has a dependent or employment relationship with the sponsor or investigator.
10. the patient is institutionalised by court or regulatory order.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: - Death within 28 days<br>- Death within 90 days<br>- Change in MOF score from baseline to day 5<br>- Multi-organ failure (> 4 MOF points) on day 7;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Baseline - day 7 after source control
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Death within 28 days<br>- Death within 90 days<br>- Change in MOF score from baseline to day 5<br>- Multi-organ failure (> 4 MOF points) on day 7;Timepoint(s) of evaluation of this end point: 5 days, 7 days, 28 days, 90 days after source control