Micro-dosing Indocyanine Green (ICG) in Children

Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.

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.

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:

1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children

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