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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
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.
Great Ormond Street Hospital for Children
London, United Kingdom
RECRUITINGMinimum clinically useful dose of ICG in children
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.
Time frame: 60 minutes (intra-operative)
Number of adverse drug events at each dose level
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
Time frame: 30 days
Surgical complications
Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.
Time frame: 30 days
Post-operative morbidity
Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.
Time frame: 90 days
Length of stay
Time in hospital post-procedure
Time frame: 90 days
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