adult intensive care patient with severe sepsis or septic shock and acute renal failure requiring renal replacement therapy MedDRA version: 13.1 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: LLT Classification code 10001041 Term: Acute renal failure System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 13.1 Level: PT Classification code 10053879 Term: Sepsis syndrome System Organ
Conditions
Interventions
Trade Name: Doribax
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Tazocin
Pharmaceutical Form: Powder for solution for injection
Sponsors
University of Tartu, Clinic of Anaesthesiology and Intensive Care
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age >= 18 years severe sepsis or septic shock as defined by the ACCP/SCC Consensus Conference acute renal failure requiring renal replacement therapy written informed consent signed by 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: contraindication for study drug use life expectancy less than 6 h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: describe the pharmacokinetics of doripenem and piperacillin-tazobactam during high volume haemofiltration;Secondary Objective: describe the whole body inflammatory response in conjunction with high volume haemofiltration;Primary end point(s): pharmacokinetic parameters of IMPs (T1/2; Cmax, Cmin, AUC0-8, T above MIC) during high volume haemofiltration therapy | — |
Countries
Estonia
Outcome results
None listed