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临床试验/NCT02850250
NCT02850250撤回不适用

Pharmacokinetics of Post Operative Cefuroxime in Infants Undergoing Cardiac Surgery

Alder Hey Children's NHS Foundation Trust0 个研究点开始时间: 2018年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Plasma concentrations

研究概览

简要总结

  • To evaluate plasma concentrations of Cefuroxime in this patient population
  • To determine if certain pathophysiological and/or iatrogenic conditions alter the pharmacokinetics in this patient group.
  • To develop a rational physiological population pharmacokinetic model that describes plasma concentrations of medications in these patients.

详细描述

Congenital heart defects are structural or functional anomalies in the heart that occur during fetal development and are present at birth. Congenital heart disease is the most common congenital structural malformation. The survival of children born with congenital heart disease has improved dramatically over the past thirty years, improvements in diagnosis, medical and surgical management as well as anaesthetic care has improved survival rates from 20% to 80%.

Paediatric cardiac surgery Children with congenital heart disease may undergo either closed or open heart surgery. In a closed operation, the heart and main blood vessels can be operated on while the heart is still beating. In open procedures, the heart is opened and the blood flow to the child's vital organs is supported by a heart-lung bypass machine (Cardio-pulmonary bypass - CBP). In light of improving outcomes recent years has seen a worldwide shift towards neonatal biventricular repair where possible. For those where repair is not possible then the majority will be offered surgical univentricular palliation typically requiring 'high-risk' surgery in the first few weeks. 'High risk' neonates undergoing cardiac surgery often spend prolonged periods on the intensive care requiring maximal support.

These patients on the intensive care unit can suffer from multi-organ failure due to a variety of reasons and may require cardiovascular and respiratory support, and also renal replacement therapy in the form of peritoneal dialysis or haemodialysis/filtration. As a result of organ failure/support and different cardiac anatomy and physiology, the pharmacokinetics of drugs used in this post-operative period could potentially vary greatly.

Post-operative surgical site infections Post operative wound infections in paediatric patients undergoing cardiothoracic surgery occurs in 2.3% to 8% of patients. This complication results in increased morbidity, longer hospitalisations and increased cost. A major strategy in reducing postoperative surgical site infections has been the use of perioperative antibiotics to reduce primarily gram-positive skin flora that colonises the skin and can potentially infect an open wound.

Of particular concern for patients undergoing cardiac surgery are deep sternal wound infections or mediastinitis. Associated mortality is significant and has been reported to be as high as 60% in adults although there is little comparable data for children.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
— 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age from birth (>37 weeks gestation) to < 3 months
  • Patients scheduled for congenital cardiac surgery and require cardiopulmonary bypass and intensive care admission post operatively in Alder Hey Children's Hospital
  • Prescription of studied medications as per standard hospital policy.
  • Intra-arterial catheter suitable for study sampling in situ.
  • Informed consent by the parent or a legally authorised representative to participate in the study and to store specimens for immediate and future analysis.

排除标准

  • No written informed consent
  • Investigator's concerns
  • Non English speaking
  • No intra-arterial catheter

结局指标

主要结局

Plasma concentrations

时间窗: 12 months

To measure plasma concentrations of Cefuroxime in this patient population

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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