severe sepsis / septic shock MedDRA version: 14.1 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: selenase T pro injectione
Product Name: Selen als Natriumselenitpentahydrat
Pharmaceutical Form: Solution for infusion
CAS Number: 10102188
Other descriptive name: SODIUM SELENITE PENTAHYD
Sponsors
Friedrich-Schiller-University of Jena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Severe sepsis or septic shock 2. Beginning of severe sepsis or of septic shock within the last 24 hours 3. age >= 18 years 4. Written informed consent of the patient or his court-appointed guardian or legal representative 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women 2. women of child bearing potential without using a highly effective method of birth control. This is defined as those which result in a low failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 3. Participation in other clinical trials within the last 30 days 4. Current participation in any other scientific investigation or any other clinical trial 5. Previous participation in this clinical trial 6. Selenium intoxication 7. Therapy restriction or adjustment (e.g. DNR - order) 8. Bad prognosis due to accompanying disease(s) 9. Close relationship to the trial physician (co-workers, relatives, colleagues) 10. presence of infection, where guidelines recommend an antimicrobiological therapy for a longer time 11. severely immunocompromised patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - effect of interventions on 28-day total mortality;Secondary Objective: - effect of interventions on 1. organ dysfunctions 2. hospital and ICU length of stay / 90-day total mortality 3. frequency and duration of mechanical ventilation 4. frequency and duration of renal replacement therapy 5. frequency and duration of therapy with vasopressors 6. safety of the interventions 7. 28-day total mortality and secondary objects 1 to 6 in the subgroup of patients, who survived at least 48 hours 8. rapid eradication of infections by Procalcitonin 9. duration, resistance and costs of antibitotic therapy by Procalcitonin ;Primary end point(s): 28-day total mortality;Timepoint(s) of evaluation of this end point: 28 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean total SOFA and SOFA subscores 2. All cause mortality 3. Frequency and duration of mechanical ventilation 4. Frequency and duration of renal replacement therapy 5. Frequency and duration of vasopressor support 6. Frequency of adverse events and severe adverse events 7. Clinical cure and microbiological cure 8. Duration of antimicrobial therapy 9. Costs of antimicrobial therapy 10. Time to change of antibiotic therapy 11. antibiotic exposure days 12. Days alive without antimicrobial therapy 13. Frequency of resistancies against antibiotics (VRE, MRSA, ESBL) 14. ICU length of stay 15. Hospital length of stay 16. Rate of surgical procedures for focus control 17. Rate of procedures to diagnose infections 18. Frequency of new infections;Timepoint(s) of evaluation of this end point: 1. ICU stay, maximal 21 days after randomisation 2. - 5. 90 days after randomisation 6. ICU stay, maximal 21 days after randomisation 7. days 4, 7, 10, 14 after randomisation 8. - 13. ICU stay, maximal 21 days after randomisation 14. - 15. 90 days after randomisation 16. - 18. ICU stay, maximal 21 days after randomisation | — |
Countries
Germany
Outcome results
None listed