Overview

This trial is active, not recruiting.

Condition replacement therapy, renal
Treatment pharmacokinetic analysis
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date July 2013
End date December 2016
Trial size 60 participants
Trial identifier NCT02287493, PV4244

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.

Plasma specimens will be quantified using high Performance liquid chromatography (HPLC).

Primary endpoint: Plasma levels of antiinfectives during SLED

Secondary endpoints:

- 28-day-mortality

- length of stay at the intensive care unit (ICU) and in hospital

- clinical and microbiological cure of infections

Inclusion criteria:

- age: > 18 years

- patients under SLED

- antiinfective treatment

exclusion criteria:

- missing informed consent

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.
pharmacokinetic analysis
Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.
pharmacokinetic analysis

Primary Outcomes

Measure
Serum levels of meropenem or ceftazidim during SLED
time frame: Pharmacokinetic measures (days 1, 3, 5 and at the end of SLED; 0, 1, 2, 4h after start of SLED and at the end of SLED))

Secondary Outcomes

Measure
28-day mortality, for inpatients
time frame: 28 days
Length of stay at the ICU and in hospital
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Clinical and microbiological cure of infections
time frame: Participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - age: 18 or older - patients receiving SLED and either meropenem or ceftazidim Exclusion Criteria: - missing informed consent

Additional Information

Official title Pharmacokinetics of Selected Antiinfectives During Sustained Low-efficiency Dialysis (SLED)
Principal investigator Stefan Kluge, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.