Overview
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.
Description
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
Eligibility
Inclusion Criteria:
- Children aged ≤18 years of age
- Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Exclusion Criteria:
- 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