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Completed

NCT Number: NCT03034174

Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

The objective of this study is to describe the pharmacokinetics of tigecycline in critically ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200 mg loading dose and 100 mg/12h).

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Key information

Conditions

Septic Shock Antibiotic Resistant Infection Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

II Department of Anesthesia and Intensive Care, Medical University of Lublin

Lublin, 20-081, Poland

About this study

This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12 hours intravenously), meropenem (2 grams every 8 hours intravenously).

Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days. The standard arterial canula will be used to obtain samples.

In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.

Serum tigecycline concentration will be measured with high performance liquid chromatography.

Each patient's hemodynamics 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 sepsis
  • age 18-80 years
  • CVVHD treatment
  • an eligible consent obtained from the patient or his/her attendant

Exclusion criteria

  • allergy to tigecycline or meropenem
  • contraindication to CVVHD
  • lack of consent to participate in the study
  • age of patients below 18 or above 80 years

Treatment and study plan

Primary outcomes

  1. Serum concentration of tigecycline

    Time frame: 72 hours for each patient from the tigecycline treatment initiation.

    Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline for 3 days.

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Registry information

Official study title

Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients: an Observational, Prospective Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 27, 2017
Registry last updated
Nov 24, 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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