Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)

Completed

• Conditions: Replacement Therapy, Renal
• Interventions: Other: Pharmacokinetic Analysis

• Registration Number: NCT02287493
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-10
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2020-11-10
• Results First Submitted QC: 2021-01-31
• Results First Posted: 2021-02-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• age: 18 or older
• patients receiving SLED and either meropenem or ceftazidim

Exclusion Criteria

• missing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Meropenem	Pharmacokinetic Analysis	Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
Ceftazidim	Pharmacokinetic Analysis	Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.

Primary Outcome Measures

Name	Time	Method
Patients Showing Serum Levels of Meropenem or Ceftazidim at the End of SLED Above the Minimal Inhibitory Concentration (MIC)	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.

Secondary Outcome Measures

Name	Time	Method
Length of Stay (LOS)	minimum duration of hospital stay, maximum 1 year	Length of stay at the ICU and in hospital
Mortality	minimum duration of hospital stay, maximum 1 year	ICU mortality
Number of Patients With Clinical Cure of Infections	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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany