Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03034174

Enrollment

Registered

2017-01-27

Start date

2017-01-15

Completion date

2018-10-10

Last updated

2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection, Critical Illness, Septic Shock

Keywords

tigecycline, pharmacokinetics

Brief summary

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).

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serum concentration of tigecycline	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.

Countries

Poland

Outcome results