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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Pieter De Cock, Prof. Apr
- 電話番号：+32 9 332 29 69
- メール：pieter.decock@uzgent.be
研究連絡先のバックアップ
- 名前：Annemie Bauters, MD.
- 電話番号：+ 32 9 332 18 83
- メール：Annemie.Bauters@UGent.be
研究場所
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Ghent、ベルギー、9000
- 募集
- Ghent University Hospital, Ghent
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コンタクト：
- Anca Amza
- 電話番号：+32 9 332 18 83
- メール：anca.amza@uzgent.be
-
主任研究者：
- Pieter De Cock, Prof. Apr.
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Standard of Care Paracetamol or Cefazolin treatment in children with normal weight
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Prophylactic Cefazolin treatment per standard-of-care
他の名前：
Preoperative dose of paracetamol, as per standard-of-care
他の名前：
|
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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
他の名前：
Preoperative dose of paracetamol, as per standard-of-care
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood concentrations of paracetamol and its metabolites
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biomarkers values: enzymes
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Anca Amza、Ghent University Hospital and Ghent Univeristy
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ONZ-2023-0432
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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