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

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

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
Meropenem
Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
Other: Pharmacokinetic Analysis
Ceftazidim
Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
Other: Pharmacokinetic Analysis

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
Length of Stay (LOS)
Time Frame: minimum duration of hospital stay, maximum 1 year
Length of stay at the ICU and in hospital
minimum duration of hospital stay, maximum 1 year
Number of Patients With Clinical Cure of Infections
Time Frame: minimum duration of hospital stay, maximum 1 year
Clinical response to antibiotic treatment assessed by laboratory parameters such as leucocyte count, c-reactive protein or procalcitonin levels as well as vasopressor support
minimum duration of hospital stay, maximum 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

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.

General Publications

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

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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