Micro-dosing Indocyanine Green (ICG) 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.
| Condition(s) | Perfusion, Fluorescence Imaging, Gastrointestinal Tract Disorders, Genitourinary Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Locations | London, United Kingdom |
| Start date | 2024-06 |
| NCT ID | NCT06421103 |
| Official listing | https://clinicaltrials.gov/study/NCT06421103 |