Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy

NCT02611271 | Unknown

• 1 other identifier: 2015-11-Studienanmeldung
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Illness; Sepsis; Acute Kidney Injury

Outcome Measures

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 \[mg/8 h dosing interval\].

  8 hours

Study Arms (2)

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

Monitoring of antibiotic drug removal OTHER

No study specific intervention will be performed

Imipenem/Cilastatin; Piperacillin/Tazobactam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients treated for sepsis on surgical intensive care unit undergoing renal replacement therapy.

You may qualify if:

• Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
• Age \> 18 y

You may not qualify if:

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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Interdisziplinäre Intensivstation ZOM 1, UKD

Düsseldorf, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Critical Illness; Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Detlef Kindgen-Milles, Prof.

  Department of Anesthesiology, Duesseldorf University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Detlef Kindgen-Milles, Prof.

CONTACT

+49 211 81; Kindgen-Milles@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. D. Kindgen-Milles

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 20, 2015
• Study Start: December 1, 2017
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

DE (1)