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Completed

NCT Number: NCT03507751

Pharmacokinetics of Meropenem During High-dose CRRT

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.

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Key information

Conditions

Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Olsztyn, 10- 561, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

1.0 gram of meropenem given intravenously every 8 hours

CRRT

Device

Continuous renal replacement therapy for three days

Primary outcomes

  1. Plasma concentration of meropenem

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • University of Warmia and Mazury in Olsztyn

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 25, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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