Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT02611271

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Dec 1, 2017

Anticipated Primary Completion Date :

Aug 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption [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].

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Interdisziplinäre Intensivstation ZOM 1, UKD	Duesseldorf		Germany	40225

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

Principal Investigator: Detlef Kindgen-Milles, Prof., Department of Anesthesiology, Duesseldorf University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Klinik für Anästhesiologie, Prof. D. Kindgen-Milles, Heinrich-Heine University, Duesseldorf

ClinicalTrials.gov Identifier:

NCT02611271

Other Study ID Numbers:

2015-11-Studienanmeldung

First Posted:

Nov 20, 2015

Last Update Posted:

May 7, 2020

Last Verified:

May 1, 2020

Additional relevant MeSH terms:

Sepsis

Acute Kidney Injury

Critical Illness

Anti-Bacterial Agents

Study Results

No Results Posted as of May 7, 2020