Pharmacokinetics of Meropenem During High-dose CRRT

November 22, 2023 updated by: Michał Borys, Medical University of Lublin

Pharmacokinetics of Meropenem During High-dose Continuous Renal Replacement Therapy in Critically Ill Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

19

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

  • Poland
      • Olsztyn, Poland, 10- 561
        • Oddział Kliniczny Anestezjologii i Intensywnej Terapii, Wojewódzki Szpital Specjalistyczny w Olsztynie

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Severely ill patients treated in ICU

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Meropenem
Patients who require meropenem and CRRT during ICU (intensive care unit) stay
Drug: Meropenem
1.0 gram of meropenem given intravenously every 8 hours
Device: CRRT
Continuous renal replacement therapy for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of meropenem
Time Frame: 3 days
3 days

Collaborators and Investigators

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

Sponsor

Medical University of Lublin

Collaborators

University of Warmia and Mazury in Olsztyn

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)

April 2, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

February 2, 2019

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90/2009/IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

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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