Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
PhA-SLED
1 other identifier
observational
35
1 country
1
Brief Summary
In a prospective, non-interventional, monocentric observational study the pharmacokinetic properties of selected antiinfective drugs during sustained low-efficiency dialysis (SLED) will be analyzed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
February 18, 2021
CompletedDecember 14, 2021
December 1, 2021
3.4 years
October 30, 2014
November 10, 2020
December 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)
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 Outcomes (3)
Mortality
minimum duration of hospital stay, maximum 1 year
Length of Stay (LOS)
minimum duration of hospital stay, maximum 1 year
Number of Patients With Clinical Cure of Infections
minimum duration of hospital stay, maximum 1 year
Study Arms (2)
Meropenem
Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
Ceftazidim
Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
Interventions
Eligibility Criteria
Adult ICU patients at University Medical Center Hamburg-Eppendorf receiving SLED and either meropenem or ceftazidim.
You may qualify if:
- age: 18 or older
- patients receiving SLED and either meropenem or ceftazidim
You may not qualify if:
- missing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Related Publications (1)
Braune S, Konig C, Roberts JA, Nierhaus A, Steinmetz O, Baehr M, Kluge S, Langebrake C. Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study. Crit Care. 2018 Jan 30;22(1):25. doi: 10.1186/s13054-018-1940-1.
PMID: 29382394DERIVED
Results Point of Contact
- Title
- Dr. Christina König
- Organization
- University Medical Center Hamburg-Eppendorf
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Kluge, Prof. Dr.
University Medical Center Hamburg-Eppendorf, Department of Intensive Care
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Clinical Research Hospital Pharmacy
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 10, 2014
Study Start
July 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
December 14, 2021
Results First Posted
February 18, 2021
Record last verified: 2021-12