DIADSORBMAB: Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis

Sponsor
Heinrich-Heine University, Duesseldorf (Other)
Overall Status
Unknown status
CT.gov ID
NCT02533609
Collaborator
Fresenius Medical Care Deutschland GmbH (Industry)
30
1
63
0.5

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) requiring renal replacement therapy is common in critically ill patients. The major causes of AKI are severe sepsis and septic shock requiring effective antibiotic treatment. Patients with sepsis on ICUs usually are haemodynamically instable so that renal replacement therapy is applied using continuous techniques. In recent years, the efficacy of renal replacement therapies has improved, namely by using regional citrate anticoagulation which improves filter lifetime and filter patency. At present, the extent of removal of antibiotic drugs using citrate-anticoagulated CVVHD in critically ill patients has not been investigated thoroughly. Thus, the investigators want to investigate

  1. whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se

  2. whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
    Study Start Date :
    Sep 1, 2015
    Anticipated Primary Completion Date :
    Aug 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Piperacillin/Tazobactam

    Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics

    Imipenem/Cilastatin

    Patients undergoing continuous veno-venous renal replacement therapy and treated with this antibiotics

    Outcome Measures

    Primary Outcome Measures

    1. Removal of antibiotic drugs during day 1 - 2 - 3 of citrate anticoagulated CVVHD (mg/d) [up to three days]

      Total hemofilter clearance (ml/min) of imipenem/cilastatin and piperacillin/tazobactam on each treatment day during an 8-hour dosing interval using blood sided clearance - Total amount of antibiotic drug which is eliminated via the filter during 24 h using filter clearance and delivered dialysis dose during 24 h

    2. Filter patency during day 1 - 2 - 3 of citrate anticoagulated CVVHD [up to three days]

      Filter patency is calculated as a function of the sieving coefficient for small solutes (i.e. creatinine and the respective antibiotic drugs) over the first 72 h, Sieving coefficient is without dimension

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Intensive care patients with acute kidney injury requiring continous renal replacement therapy with citrate-anticoagulation

    • Age > 18 y

    Exclusion Criteria:
    • < 18 y

    • Pregnancy

    • Contraindications against citrate-anticoagulation or continous renal replacement therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prof. Kindgen-Milles Duesseldorf Germany 40225

    Sponsors and Collaborators

    • Heinrich-Heine University, Duesseldorf
    • Fresenius Medical Care Deutschland GmbH

    Investigators

    • Study Director: Detlef Kindgen-Milles, Prof., Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Klinik für Anästhesiologie, Prof. Dr. D. Kindgen-Milles, Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT02533609
    Other Study ID Numbers:
    • 2015-02-ENDVERSION
    First Posted:
    Aug 27, 2015
    Last Update Posted:
    May 11, 2020
    Last Verified:
    May 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2020