- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02533609
Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis (DIADSORBMAB)
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
- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during citrate-anticoagulated CVVHD per se
- whether filter patency during citrate-anticoagulated CVVD remains stable during a treatment period of 72 h
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Duesseldorf, Germany, 40225
- Prof. Kindgen-Milles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
up to three days
|
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
|
up to three days
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Detlef Kindgen-Milles, Prof., Department of Anesthesiology
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-02-ENDVERSION
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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