Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

• Conditions: Acute Kidney Injury; Critical Illness; Sepsis
• Interventions: Other: Monitoring of antibiotic drug removal

• Registration Number: NCT02611271
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate

- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock

Detailed Description

Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.

Study Timeline

• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Study Start: 2017-12-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-07
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
• Age > 18 y

Exclusion Criteria

• < 18 y
• Pregnancy
• Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Piperacillin/Tazobactam	Monitoring of antibiotic drug removal	Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis
Imipenem/Cilastatin	Monitoring of antibiotic drug removal	Critically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis

Primary Outcome Measures

Name	Time	Method
Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption	8 hours	Removal of antibiotic drugs during combined CRRT and adsorption will be evaluated by calculating total filter clearance using the drug concentration pre- and postfilter as well as the dialysate concentration. The adsorptive clearance will be evaluated using the pre- and postadsorber concentration. The outcome measure will be removal of antibiotic drug \[mg/8 h dosing interval\].

Trial Locations

Locations (1)

Interdisziplinäre Intensivstation ZOM 1, UKD; 🇩🇪 Duesseldorf, Germany