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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Pieter De Cock, Prof. Apr
- 电话号码：+32 9 332 29 69
- 邮箱：pieter.decock@uzgent.be
研究联系人备份
- 姓名：Annemie Bauters, MD.
- 电话号码：+ 32 9 332 18 83
- 邮箱：Annemie.Bauters@UGent.be
学习地点
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Ghent、比利时、9000
- 招聘中
- Ghent University Hospital, Ghent
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接触：
- Anca Amza
- 电话号码：+32 9 332 18 83
- 邮箱：anca.amza@uzgent.be
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首席研究员：
- Pieter De Cock, Prof. Apr.
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Standard of Care Paracetamol or Cefazolin treatment in children with normal weight
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Prophylactic Cefazolin treatment per standard-of-care
其他名称：
Preoperative dose of paracetamol, as per standard-of-care
其他名称：
|
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Standard of Care Paracetamol or Cefazolin treatment in children with overweight
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Prophylactic Cefazolin treatment per standard-of-care
其他名称：
Preoperative dose of paracetamol, as per standard-of-care
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood concentrations of paracetamol and its metabolites
大体时间：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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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
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Biomarkers values: enzymes
大体时间：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
大体时间：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)
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合作者和调查者
调查人员
- 研究主任：Anca Amza、Ghent University Hospital and Ghent Univeristy
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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