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

NCT ID: NCT02287493

Last Updated: 2021-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Replacement Therapy, Renal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Meropenem

Adult ICU patients receiving meropenem during SLED will be analyzed for meropenem pharmacokinetics.

Pharmacokinetic Analysis

Intervention Type OTHER

Ceftazidim

Adult ICU patients receiving ceftazidim during SLED will be analyzed for ceftazidim pharmacokinetics.

Pharmacokinetic Analysis

Intervention Type OTHER

Interventions

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Pharmacokinetic Analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* missing informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. rer. medic. Claudia Langebrake

Head Clinical Research Hospital Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Kluge, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Hamburg-Eppendorf, Department of Intensive Care

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29382394 (View on PubMed)

Other Identifiers

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PV4244

Identifier Type: -

Identifier Source: org_study_id