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Micro-dosing Indocyanine Green (ICG) in Children

ConditionsPerfusionFluorescence ImagingGastrointestinal Tract DisordersGenitourinary Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorGreat Ormond Street Hospital for Children NHS Foundation Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged ≤18 years of age

Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

Disqualifiers

Renal and liver dysfunction

Active infection

Coagulopathy

Complex congenital heart defect

Trial design

Design model

Single group

Treatments tested in this trial

  • Indocyanine Green (ICG)

    Drug

    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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Micro-dosing Indocyanine Green (ICG)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Minimum 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)
2

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

Secondary outcomes

1

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
2

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
3

Length of stay

Time in hospital post-procedure

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Great Ormond Street Hospital for Children NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov
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