Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

Sepsis Clinical Trial

Official title:

Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611271
• Other study ID #: 2015-11-Studienanmeldung
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Detlef Kindgen-Milles, Prof.
• Phone: +49 211 81
• Email: Kindgen-Milles[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Sepsis

Intervention

Other:
• Monitoring of antibiotic drug removal
No study specific intervention will be performed

Locations

Country	Name	City	State
Germany	Interdisziplinäre Intensivstation ZOM 1, UKD	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption	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].	8 hours