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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2020

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Removal of antibiotic drugs during day 1 – 2 – 3 of citrate anticoagulated CVVHD (mg/d)
    • Time Frame: 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
  • Filter patency during day 1 – 2 – 3 of citrate anticoagulated CVVHD
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Heinrich-Heine University, Duesseldorf
  • Collaborator
    • Fresenius Medical Care Deutschland GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: Klinik für Anästhesiologie, Prof. Dr. D. Kindgen-Milles – Heinrich-Heine University, Duesseldorf
  • Overall Official(s)
    • Detlef Kindgen-Milles, Prof., Study Director, Department of Anesthesiology

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.