CClinicalTrials.gg
Status unknownNCT02611271Updated May 7, 2020

Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

An observational study in Critical Illness, Sepsis and Acute Kidney Injury, sponsored by Heinrich-Heine University, Duesseldorf. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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
Read the detailed description

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

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Conditions studied

  • Critical Illness
  • Sepsis
  • Acute Kidney Injury
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 30 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • \< 18 y
  • Pregnancy
  • Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Piperacillin/Tazobactam

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

    Other: Monitoring of antibiotic drug removal

  • Imipenem/Cilastatin

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

    Other: Monitoring of antibiotic drug removal

Interventions

  • OtherMonitoring of antibiotic drug removal

    No study specific intervention will be performed

06

What researchers measure

Primary outcomes

  1. 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 \[mg/8 h dosing interval\].

    Time frame: 8 hours

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02611271
Lead sponsor
Heinrich-Heine University, Duesseldorf
Responsible party
Klinik für Anästhesiologie (Prof. D. Kindgen-Milles, Heinrich-Heine University, Duesseldorf) — Principal investigator
First posted
Nov 20, 2015
Start date
Dec 1, 2017
Primary completion
Aug 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
May 7, 2020

Study contacts

Detlef Kindgen-Milles, Prof.
Contact
Kindgen-Milles@med.uni-duesseldorf.de
+49 211 81 ext. 07047
Detlef Kindgen-Milles, Prof.
principal investigator · Department of Anesthesiology, Duesseldorf University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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