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Development of a new dosing strategy of vancomycin using target concentration-controlled infusion

Development of a new dosing strategy of vancomycin using target concentration-controlled infusion

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0003462
Enrollment
386
Registered
2019-01-31
Start date
2019-03-25
Completion date
Unknown
Last updated
2020-05-18

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

Conditions

None listed

Interventions

Procedure/Surgery, Others : This study consists of three sub-studies. The purpose of the first sub-study is to construct a pharmacokinetic model of vancomycin in patients with normal renal function. T

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 1st group, Development of a pharmacokinetic model for vancomycin in ICU patients with normal renal function or mild decreased renal function. 1. Patients over 20 years of age. 2. Patients who hospitalized in surgical intensive care unit of the Asan medical center. 3. Patients in clinical need for vancomycin administration 4. Patients over 60ml/min of glomerular filtration rate, on preoperative laboratory check. 5. Patients over 40 kg of body weight. 6. Patients who voluntarily agreed to be enrolled to the clinical research, or the case which the protector of the patient agreed to be enrolled to the clinical research, instead of the sedated patient. - 2nd group, Development of a pharmacokinetic model for vancomycin in ICU patients with CRRT 1. Patients over 20 years of age. 2. Patients who hospitalized in surgical intensive care unit of the Asan medical center. 3. Patients in clinical need for vancomycin administration 4. Patients who receiving continuous renal replacement therapy(CRRT). 5. Patients over 40 kg of body weight. 6. Patients who voluntarily agreed to be enrolled to the clinical research, or the case which the protector of the patient agreed to be enrolled to the clinical research, instead of the sedated patient. - 3rd and 4th group, Comparison of vancomycin therapeutic effectiveness between standard administration method versus TCI method, in patients with normal renal function 1. Patients over 20 years of age. 2. Patients who hospitalized in surgical intensive care unit of the Asan medical center. 3. Patients in clinical need for vancomycin administration 4. Patients over 60ml/min of glomerular filtration rate, on preoperative laboratory check. 5. Patients over 40 kg of body weight. 6. Patients who voluntarily agreed to be enrolled to the clinical research, or the case which the protector of the patient agreed to be enrolled to the clinical research, instead of the sedated patient.

Exclusion criteria

Exclusion criteria: - 1st group, Development of a pharmacokinetic model for vancomycin in ICU patients with normal renal function or mild decreased renal function. 1. Pregnant female, or female who breast-feeds her baby. 2. Patients who has history of hypersensitivity to the vancomycin. 3. Patients who has history of prior vancomycin administration, within 7 days of the clinical research enroll agreement. 4. Patients below 8 g/dl of hemoglobin concentration. 5. Patients below 60ml/min of glomerular filtration rate, on preoperative laboratory check. 6. Other in-appropriative patients under the researcher's decision. - 2nd group, Development of a pharmacokinetic model for vancomycin in ICU patients with CRRT 1. Pregnant female, or female who breast-feeds her baby. 2. Patients who has history of hypersensitivity to the vancomycin. 3. Patients who has history of prior vancomycin administration, within 7 days of the clinical research enroll agreement. 4. Patients below 8 g/dl of hemoglobin concentration. 5. Other in-appropriative patients under the researcher's decision. - 3rd and 4th group, Comparison of vancomycin therapeutic effectiveness between standard administration method versus TCI method, in patients with normal renal function 1. Pregnant female, or female who breast-feeds her baby. 2. Patients who has history of hypersensitivity to the vancomycin. 3. Patients who has history of prior vancomycin administration, within 7 days of the clinical research enroll agreement. 4. Patients below 8 g/dl of hemoglobin concentration. 5. Patients below 60ml/min of glomerular filtration rate, on preoperative laboratory check. 6. Other in-appropriative patients under the researcher's decision.

Design outcomes

Primary

MeasureTime frame
Incidence of acute kidney injury;The volume of distribution and clearance of the vancomycin.

Secondary

MeasureTime frame
Predictive performance of the pharmacokinetic model.

Countries

Korea, Republic of

Contacts

Public ContactByungmoon Choi

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026