Pharmacokinetics of Meropenem During High-dose CRRT

NCT ID: NCT03507751

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-02-02

Brief Summary

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Assessment of meropenem plasma concentration in critically ill patients who require CRRT (continuous renal replacement therapy). A standard dose of meropenem is administered, i.e. 1 gram every 8 hours.

Detailed Description

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This is a prospective observational study performed on critically ill patients. Inclusion criteria are a severe infection on admission requiring the use of meropenem and CRRT.

Both medical and surgical patients will be included. Any type of infections can be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes one-hour infusion of meropenem (1.0 gram) intravenously every 8 hours.

Blood samples (2 mL) will be collected at the 15, 30, 45, 60, 75, 90, 120, 180, 240, and 480 minutes after each dose of meropenem for 3 consecutive days. The standard arterial canula will be used to obtain samples.

30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum meropenem concentration will be measured by high-performance liquid chromatography.

Each patient's hemodynamic parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies, i.e. ventilatory support, sedation, an antifungal agent will be given as required.

Conditions

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Infection Renal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Meropenem

Patients who require meropenem and CRRT during ICU (intensive care unit) stay

Meropenem

Intervention Type DRUG

1.0 gram of meropenem given intravenously every 8 hours

CRRT

Intervention Type DEVICE

Continuous renal replacement therapy for three days

Interventions

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Meropenem

1.0 gram of meropenem given intravenously every 8 hours

Intervention Type DRUG

CRRT

Continuous renal replacement therapy for three days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who require ICU treatment due to severe infection
* age 18-80 years
* an eligible consent obtained from the patient or his/her attendant

Exclusion Criteria

* allergy to meropenem
* lack of consent to participate in the study
* age of patients below 18 or above 80 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Warmia and Mazury in Olsztyn

OTHER

Sponsor Role collaborator

Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

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Michał Borys

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie

Olsztyn, , Poland

Site Status

Countries

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Poland

Other Identifiers

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90/2009/IV

Identifier Type: -

Identifier Source: org_study_id