Using low doses of Indocyanine Green in children during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cohort study aims to determine the lowest effective dose of Indocyanine Green (ICG) for assessing gastrointestinal and genitourinary tract perfusion in children during surgery. It will involve a single center, open-label, dose escalation approach to identify the minimal clinically useful dose while also evaluating the safety profile of ICG in pediatric patients. The study will characterize the intra-operative fluorescence of ICG to improve surgical outcomes in children undergoing elective procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Great Ormond Street Hospital for Children
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Stefano Giuliani — Great Ormond Street Hospital
• Study coordinator: Stefano Giuliani
• Email: stefano.giuliani@gosh.nhs.uk
• Phone: 02074059200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.