Liver Function Assessment - Feasibility and Dosing Study

Not Applicable

Terminated

• Conditions: Hepatic Failure
• Interventions: Drug: ICG Dye

• Registration Number: NCT02516319
• Lead Sponsor: Cardiox Corporation

Brief Summary

The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.

Detailed Description

Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-05
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-14
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Male or female subjects, aged 18 to 75 years, inclusive
• Informed consent documentation understood and signed.

Exclusion Criteria

• Known allergy or sensitivity to the ICG or to iodide contrast dye
• Pregnant women or those nursing babies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serial Blood Draws	ICG Dye	Cohorts 3 and 4 - weight based doses of ICG dye followed by serial blood draws at 5, 10, 15 and 20 minutes post ICG injection.
Liver Funtion Test Dye Detection Monitor	ICG Dye	All cohorts receive continuous LFT monitoring post ICG injection.

Primary Outcome Measures

Name	Time	Method
ICG dye detection using the LFT system compared to serial blood sampling ethods.	20 minutes post ICG dose	Determination of an adequate dose for the Cardiox Liver Functioning Assessment LFA system to produce liver function assessments consistent with serial blood sampling methods.

Secondary Outcome Measures

Name	Time	Method
Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.	20 minutes post ICG dose
ICG fluorescence detection at the scaphoid fossa of the ears	20 minutes post ICG dose