Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients

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

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-15

Study Completion Date

2018-10-10

Brief Summary

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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

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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.

Conditions

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Septic Shock Antibiotic Resistant Infection Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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tigecycline

Each patient will receive: tigecycline (200 mg q 12 hours i.v.), meropenem (2 g q 8 hours i.v). In each case CVVHD will be started.

Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Michał Borys

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirosław Czuczwar, M.D. PhD.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lublin

Locations

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

Lublin, , Poland

Site Status

Countries

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Poland

Other Identifiers

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KE-0254/258/2014

Identifier Type: -

Identifier Source: org_study_id