Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED) (PhA-SLED)
December 13, 2021 updated by: PD Dr. rer. medic. Claudia Langebrake, Universitätsklinikum Hamburg-Eppendorf
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Antibiotic concentrations are measured whilst patients receive SLED for renal replacement therapy. The plasma specimens will be quantified using high Performance liquid chromatography (HPLC).
Primary endpoint:
- Plasma levels of antiinfectives during SLED
Secondary endpoints:
- mortality
- length of stay at the intensive care unit (ICU) and hospital
- clinical cure of infections
Inclusion criteria:
- age: > 18 years
- patients under SLED
- antiinfective treatment
exclusion criteria:
- missing informed consent
Study Type
Observational
Enrollment (Actual)
35
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.
Description
Inclusion Criteria:
- age: 18 or older
- patients receiving SLED and either meropenem or ceftazidim
Exclusion Criteria:
- missing informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Meropenem
Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
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Ceftazidim
Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
Time Frame: days receiving SLED, up to 5 days
|
Plasma concentrations of meropenem or ceftazidim by the end of SLED therapy. Meropenem and ceftazidim are often used for empirical treatment also targeting for Pseudomonas aeruginosa (PSA) infections. Therefore, minimal targeted concentrations were set to the MIC of 2 mg/l for meropenem and to the MIC of 4 mg/L for ceftazidime treatment according to the breakpoints of PSA strains. |
days receiving SLED, up to 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: minimum duration of hospital stay, maximum 1 year
|
ICU mortality
|
minimum duration of hospital stay, maximum 1 year
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Length of Stay (LOS)
Time Frame: minimum duration of hospital stay, maximum 1 year
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Length of stay at the ICU and in hospital
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minimum duration of hospital stay, maximum 1 year
|
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Number of Patients With Clinical Cure of Infections
Time Frame: minimum duration of hospital stay, maximum 1 year
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Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support
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minimum duration of hospital stay, maximum 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefan Kluge, Prof. Dr., University Medical Center Hamburg-Eppendorf, Department of Intensive Care
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 30, 2014
First Submitted That Met QC Criteria
November 5, 2014
First Posted (Estimate)
November 10, 2014
Study Record Updates
Last Update Posted (Actual)
December 14, 2021
Last Update Submitted That Met QC Criteria
December 13, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PV4244
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