Liver Function Assessment - Feasibility and Dosing Study

Cardiox

Status: Terminated

Conditions: Hepatic Failure

Treatments: Drug: ICG Dye

Study type: Interventional

Funder types: Industry

Identifiers

NCT02516319

LFA-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 2 patient groups

Serial Blood Draws

Active Comparator group

Description:

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.

Treatment:

Drug: ICG Dye

Liver Funtion Test Dye Detection Monitor

Experimental group

Description:

All cohorts receive continuous LFT monitoring post ICG injection.

Treatment:

Drug: ICG Dye