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: 21.1 Level: LLT Classification code 10081559 Term: Septic peritonitis System Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations MedDRA version: 20
Conditions
Interventions
Trade Name: Pentaglobin
Product Name: Pentaglobin
Pharmaceutical Form: Infusion
Sponsors
University Hospital Aachen, AöR, Dean of the Medical Faculty of the RWTH Aachen for the Managing Board of the University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 ( 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Death within 28 days - Death within 90 days - Change in MOF score from baseline to day 5 - 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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 - Death within 90 days - Change in MOF score from baseline to day 5 - 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 | — |
Countries
Austria, Germany
Contacts
Public ContactCTC-A
University Hospital RWTH Aachen
Outcome results
None listed