Status:
RECRUITING
Clinical Study of Individualized Vancomycin Dosing Based on Population PK Model
Lead Sponsor:
Central South University
Conditions:
Severe Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to compare the clinical efficacy of individualized dosing based on the population pharmacokinetics (PK) model and empirical dosing of vancomycin in participants with...
Detailed Description
1. Research purpose The goal of this clinical trial is to compare the clinical efficacy of individualized dosing based on the population pharmacokinetics (PK) model and empirical dosing of vancomycin ...
Eligibility Criteria
Inclusion
- Admission to neurological intensive care unit (NICU).
- Age ≥18 years old. Participants will be eligible if they meet both of these criteria.
Exclusion
- Evidence of absolute renal impairment, which included Serum creatinine (SCR) ≥133 μmol/L at admission, development of acute kidney injury (AKI) after admission, need for renal replacement therapy during hospitalization, renal related tests suggestive of renal disease, and previous history of renal replacement therapy or chronic kidney disease.
- Pregnant participants.
- Primary diagnosis is non-neurological disease.
- The height or weight of participants is not recorded in the medical record system.
- The frequency of SCR monitoring was less than 3 times. Participants who meet any of these criteria will be excluded.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06161870
Start Date
January 1 2021
End Date
December 1 2024
Last Update
December 8 2023
Active Locations (1)
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1
Central South University
Changsha, Hunan, China, 410000