Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

NCT ID: NCT02611271

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-31

Brief Summary

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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

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

Conditions

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Critical Illness Sepsis Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Piperacillin/Tazobactam

Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis

Monitoring of antibiotic drug removal

Intervention Type OTHER

No study specific intervention will be performed

Imipenem/Cilastatin

Critically ill patients teated with imipenem/cilastatin undergoing renal replacement therapy and cytosorb absorption during sepsis

Monitoring of antibiotic drug removal

Intervention Type OTHER

No study specific intervention will be performed

Interventions

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Monitoring of antibiotic drug removal

No study specific intervention will be performed

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Anästhesiologie

Prof. D. Kindgen-Milles

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Detlef Kindgen-Milles, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Duesseldorf University Hospital

Locations

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Interdisziplinäre Intensivstation ZOM 1, UKD

Düsseldorf, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Detlef Kindgen-Milles, Prof.

Role: CONTACT

+49 211 81 ext. 07047

Facility Contacts

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Detlef Kindgen-Milles, Prof.

Role: primary

0049 211 81 ext. 07047

Other Identifiers

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2015-11-Studienanmeldung

Identifier Type: -

Identifier Source: org_study_id

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