Paracetamol and Cefazolin Pharmacokinetics in Normal Weight and Overweight Children (TISSUE)
Pharmacokinetic evaluations will be conducted to characterize the cefazolin plasma concentration-time profile, cefazolin penetration into subcutaneous adipose tissue, and paracetamol metabolization as assessed through blood sampling. The study population consists of children aged 2 to 15 years with either normal weight or overweight. All participants are admitted for a minor elective surgical procedure and will receive paracetamol and/or cefazolin as part of standard perioperative care.
During the procedure, multiple blood and tissue-fluid samples will be collected to quantify paracetamol and cefazolin concentrations in the bloodstream, as well as cefazolin concentrations in subcutaneous adipose tissue. The study aims to characterize drug concentration-time profiles in blood (paracetamol), plasma (cefazolin), and adipose tissue (cefazolin), and to compare these pharmacokinetic parameters between normal-weight and overweight children.
These data are essential to determine whether standard dosing regimens provide adequate drug exposure across different weight categories. Previous research indicates that achieving specific target concentrations in blood and tissue is necessary for optimal therapeutic effect, yet uncertainty remains regarding appropriate dosing in overweight children.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Pieter De Cock, Prof. Apr
- 전화번호: +32 9 332 29 69
- 이메일: pieter.decock@uzgent.be
연구 연락처 백업
- 이름: Annemie Bauters, MD.
- 전화번호: + 32 9 332 18 83
- 이메일: Annemie.Bauters@UGent.be
연구 장소
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Ghent, 벨기에, 9000
- 모병
- Ghent University Hospital, Ghent
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연락하다:
- Anca Amza
- 전화번호: +32 9 332 18 83
- 이메일: anca.amza@uzgent.be
-
수석 연구원:
- Pieter De Cock, Prof. Apr.
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patient admitted to the operating room for minor elective surgery
- Patients undergoing general anesthesia for minor elective surgery
- Patient age: children from 2 years to 15 years
- Patients receiving cefazolin or paracetamol according to the standard procedure
- Intra-arterial (preferred) or intravenous access available for blood sampling
- BMI
Exclusion Criteria:
- Personal or family history of excessive bleeding
- Pre-existing coagulopathy and/or thrombocytopenia
- No catheter available for blood sampling
- Absence of parental consent
- Known allergy to one of the components of the study
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Standard of Care Paracetamol or Cefazolin treatment in children with normal weight
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Prophylactic Cefazolin treatment per standard-of-care
다른 이름들:
Preoperative dose of paracetamol, as per standard-of-care
다른 이름들:
|
|
Standard of Care Paracetamol or Cefazolin treatment in children with overweight
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Prophylactic Cefazolin treatment per standard-of-care
다른 이름들:
Preoperative dose of paracetamol, as per standard-of-care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood concentrations of paracetamol and its metabolites
기간: Blood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase
|
Blood concentrations (mg/L) of paracetamol and its metabolites: glucuronide-, sulfate-, cysteine- and mercapturate-conjugates after a single intravenous perfusion of paracetamol.
Samples collected with Volumetric Absorptive Microsampling (VAMS).
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Blood VAMS samples collected at day0 (D0): 1) before infusion(D0): predose , 2) 5 minutes after infusion (D0), 3) 5-120 minutes after infusion (D0): distribution phase, 4) 2 hours after infusion (D0), 5) 3-5 hours after infusion (D0): elimination phase
|
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Cefazolin plasma and tissue concentrations
기간: At D0 sampled: Plasma: 1) predose, 2) 5 minutes after infusion, 3) 5-120 minutes, 4) 2 hours, 5) 3-5 hours; Microdialysis: 1) baseline (-30 - 0 minutes), 2) first 2 hours after dosing (every 30 minutes a sample), 3) next 3 hours (every 1 hour a sample)
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Plasma concentrations (mg/L) are stored in heparine blood tubes.
Tissue concentrations (mg/L) are collected with a microdialysis device and stored in specific microdialysis vials.
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At D0 sampled: Plasma: 1) predose, 2) 5 minutes after infusion, 3) 5-120 minutes, 4) 2 hours, 5) 3-5 hours; Microdialysis: 1) baseline (-30 - 0 minutes), 2) first 2 hours after dosing (every 30 minutes a sample), 3) next 3 hours (every 1 hour a sample)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Biomarkers values: enzymes
기간: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
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Determination of the presence and concentration of enzymes based on the values Aspartate aminotransferase (AST; U/L), Alanine aminotransferase (ALT; U/L), and Gamma-Glutamyl transpeptidase (GGT; U/L).
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Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
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Biomarker values: proteins
기간: Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
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Determination of the presence and concentration of proteins based on the values Bilirubin (total & direct; g/L), serum creatinine (SCR; g/L), total protein (g/L), Albumin (g/L), and C-reactive protein (CRP; g/L).
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Blood was collected togheter with blood sample 4 for cefazolin concentrations, 2 hours after drug administration on day0 (D0)
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Anca Amza, Ghent University Hospital and Ghent Univeristy
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ONZ-2023-0432
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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