RecruitingNot ApplicableNCT06421103

Micro-dosing Indocyanine Green (ICG) in Children

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


Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Enrollment

90 participants

Start Date

Jun 1, 2024

Study Type

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

Max Age: 18 Years

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

DRUGIndocyanine Green (ICG)

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)

Great Ormond Street Hospital for Children

London, United Kingdom

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NCT06421103


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