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Trial record 7 of 19 for:    cytosorb

Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

This study is not yet open for participant recruitment.
Verified September 2017 by Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
Sponsor:
ClinicalTrials.gov Identifier:
NCT02611271
First Posted: November 20, 2015
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
  Purpose

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


Condition Intervention
Critical Illness Sepsis Acute Kidney Injury Other: Monitoring of antibiotic drug removal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury

Resource links provided by NLM:


Further study details as provided by Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption [ Time Frame: 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].


Estimated Enrollment: 30
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Piperacillin/Tazobactam
Critically ill patients teated with piperacillin/tazobactam undergoing renal replacement therapy and cytosorb absorption during sepsis
Other: Monitoring of antibiotic drug removal
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
Other: Monitoring of antibiotic drug removal
No study specific intervention will be performed

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients treated for sepsis on surgical intensive care unit undergoing renal replacement therapy.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611271


Contacts
Contact: Detlef Kindgen-Milles, Prof. +49 211 81 ext 07047 Kindgen-Milles@med.uni-duesseldorf.de

Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Detlef Kindgen-Milles, Prof. Department of Anesthesiology, Duesseldorf University Hospital
  More Information

Responsible Party: Klinik für Anästhesiologie, Prof. D. Kindgen-Milles, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT02611271     History of Changes
Other Study ID Numbers: 2015-11-Studienanmeldung
First Submitted: November 3, 2015
First Posted: November 20, 2015
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Sepsis
Acute Kidney Injury
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Disease Attributes
Anti-Bacterial Agents
Tazobactam
Piperacillin
Piperacillin, tazobactam drug combination
Antibiotics, Antitubercular
Cilastatin
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors