Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Minimum clinically useful dose of ICG in children
研究概览
简要总结
The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.
详细描述
Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.
This is a single centre open-label dose escalation study that aims to:
- identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
- assess the safety profile of intra-operative ICG in children
- characterise the intra-operative fluorescence of ICG in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged ≤18 years of age
- •Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
排除标准
- •Renal and liver dysfunction
- •Active infection
- •Coagulopathy
- •Complex congenital heart defect
- •Previous documented allergy to ICG injection or other iodinated contrast agents
- •Patients suffering from hyperthyroidism or autonomic thyroid adenomas
- •Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk
- •Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations
研究组 & 干预措施
Micro-dosing Indocyanine Green (ICG)
Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol.
干预措施: Indocyanine Green (ICG) (Drug)
结局指标
主要结局
Minimum clinically useful dose of ICG in children
时间窗: 60 minutes (intra-operative)
Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon.
Number of adverse drug events at each dose level
时间窗: 30 days
An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product
次要结局
- Surgical complications(30 days)
- Post-operative morbidity(90 days)
- Length of stay(90 days)