High volume haemodiafiltration in treatment of severe sepsis -- impact on pharmacokinetics of doripenem and piperacillin tazobactam and inflammatory response

• Conditions: adult intensive care patient with severe sepsis or septic shock and acute renal failure requiring renal replacement therapy; MedDRA version: 13.1Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 13.1Level: LLTClassification code 10001041Term: Acute renal failureSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 13.1Level: PTClassification code 10053879Term: Sepsis syndromeSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-000644-16-EE
• Lead Sponsor: niversity of Tartu, Clinic of Anaesthesiology and Intensive Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-24
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

contraindication for study drug use
life expectancy less than 6 h

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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