Micro-dosing Indocyanine Green (ICG) in Children
Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
Great Ormond Street Hospital for Children NHS Foundation Trust
90 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Children aged ≤18 years of age
- Elective surgery including gastrointestinal or genitourinary tract perfusion assessment
Exclusion Criteria8
- 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
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Interventions
Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06421103