CytoSorbents Corporation (CTSO)

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Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

View of NCT02611271 on 2015_11_19

ClinicalTrials Identifier: NCT02611271
Updated: 2015_11_19
Descriptive Information
Brief title
Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

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

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 type Observational
Study design Cohort
Study design Prospective
Primary outcome Measure: Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption
Time Frame: 8 hours
Safety Issue? Yes
Description:
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].

Enrollment 30 (Anticipated)
Condition Critical Illness
Condition Sepsis
Condition Acute Kidney Injury
Arm/Group
Arm Label: Piperacillin/Tazobactam
Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis

Arm/Group
Arm Label: Imipenem/Cilastatin
Critically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis

Intervention
Other: Monitoring of antibiotic drug removal Arm Label: Piperacillin/Tazobactam
Recruitment Information
Status Not yet recruiting
Start date 2015-11
Last follow-up date 2016-08 (Anticipated)
Primary completion date 2016-06 (Anticipated)
Criteria
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

Gender Both
Minimum age 18 Years
Healthy volunteers No
Administrative Data
Organization name Heinrich-Heine University, Duesseldorf
Organization study ID 2015-11-Studienanmeldung
Sponsor Heinrich-Heine University, Duesseldorf
Health Authority Germany: Ethics Commission

https://clinicaltrials.gov/ct2/results?term=CytoSorb&pg=1