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Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

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ClinicalTrials.gov Identifier: NCT02611271
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Klinik für Anästhesiologie, 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


Condition or disease Intervention/treatment
Critical Illness Sepsis Acute Kidney Injury Other: Monitoring of antibiotic drug removal

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
Estimated Enrollment : 30 participants
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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].



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Locations
Germany
Interdisziplinäre Intensivstation ZOM 1, UKD Recruiting
Duesseldorf, Germany, 40225
Contact: Detlef Kindgen-Milles, Prof.    0049 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

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 Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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
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