Pharmacokinetics Clinical Trial
Official title:
Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO
Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 30, 2022 |
| Est. primary completion date | December 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - critically ill hospitalized males or nonpregnant females aged =18 years with severe infections which the treating clinician was treating with tigecycline. Exclusion Criteria: - People who had taken tigecycline in the past week - People who were pregnant - People who had coagulation dysfunction |
| Country | Name | City | State |
|---|---|---|---|
| China | Southern medical university Nanfang hospital | Guangzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Nanfang Hospital of Southern Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum drug concentration of tigecycline | Serum drug concentration at different time points in each adult ICU patient treated with ECMO | predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose |
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