Liver Failure Clinical Trial
Official title:
A Pivotal, Within Subject, Comparison of the LFT™ Dye Monitor System to the Indocyanine Green Dye (ICG) Serial Blood Plasma Disappearance Rate in Patients With Impaired and Non-Impaired Hepatic Function
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum ICG PDR.
Indocyanine green (ICG) is a water-soluble, non-toxic tricarbocyanine dye, extracted
principally by hepatic parenchymal cells and excreted almost entirely into the bile without
enterohepatic circulation. Clinically, its elimination rate is used primarily to measure
hepatic function and liver blood flow. ICG studies are also used in ophthalmic angiography
and the determination of cardiac output.
Beginning about 1959, the first human clinical studies were reported wherein an indocyanine
green (ICG) bolus was injected into a vein, and then blood samples were withdrawn over a
period of time and analyzed for ICG concentrations. This method is referred to hereinafter
as the serial blood sampling method. These blood samples are sent to a clinical laboratory
for a multi-step process of centrifuging, separation and spectrophotometric measurements of
ICG levels. The laboratory-based measured levels of residual ICG levels are then used to
determine the ICG clearance rate and R15 value or residual amount of dye remaining after 15
minutes, expressed as a percentage of the initial concentration.
As an alternative to the time- and labor-consuming serial blood sampling method, a
non-invasive technique was first reported nearly 20 years ago. In the first published
clinical study, Ishigami reported the use of a pulse dye densitometry (PDD) method to
transcutaneously detect the rate of clearance of ICG from the bloodstream to be referred to
hereinafter as dynamic liver function testing.
PDD expresses ICG elimination in terms of the indocyanine green plasma disappearance rate
because only relative ICG concentration changes are assessed. The results of this
noninvasive method have been shown to correlate with those obtained by the invasive method
used in critically ill patients (hemodynamically unstable and stable), and in patients after
liver surgery.
ICG elimination rate after liver transplantation measured by either invasive or noninvasive
ICG methods is widely used to evaluate graft function. Studies have shown that ICG
elimination, measured on the day of transplantation, reflects graft function and can be used
to predict graft viability and the expected survival of the patient. Sequential measurements
of ICG elimination between days 0 and 28 of transplantation, have been shown to predict
clinical outcome in the early postoperative period after living donor transplantation. All
of the studies have shown that the ICG elimination rate is an accurate test for evaluating
liver dysfunction, but lacks the ability to differentiate the underlying causes of the
hepatic dysfunction.
Unlike all currently existing PDD methods for performing liver function testing, LFT Dye
Monitor System employs a more sensitive method for the transcutaneous measurement of ICG
concentration level in the blood using NIR fluorescence, with a sensor that is attached
loosely to the scaphoid fossa of the ear. Thus, the chemical properties of ICG dye to
fluoresce when properly excited are used in the LFT system to enable much lower
concentrations of ICG to be detectable.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03791190 -
RCA for CRRT in Liver Failure and High Risk Bleeding Patients
|
N/A | |
Recruiting |
NCT05989958 -
The Safety and Tolerability Study of HepaCure in Chinese Subjects With Acute-On-Chronic Liver Failure
|
Phase 1 | |
Completed |
NCT02557724 -
Mobilization of Mesenchymal Stem Cells During Liver Transplantation
|
||
Recruiting |
NCT01698723 -
A Trial of Ribavirin in Patients With ACLF Due to Hepatitis E Virus
|
Phase 2 | |
Completed |
NCT01425385 -
Autoregulation Assessment During Liver Transplantation
|
N/A | |
Completed |
NCT01404793 -
SPME For Metabolomics And Concomitant Measurements Of Rocuronium Bromide Levels In Liver Transplantation
|
N/A | |
Completed |
NCT03864497 -
Myocardial Perfusion Imaging in Liver Transplantation Candidates
|
||
Completed |
NCT00808691 -
Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit
|
N/A | |
Completed |
NCT00287235 -
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
|
N/A | |
Completed |
NCT03650920 -
Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients
|
N/A | |
Recruiting |
NCT05517668 -
Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose
|
Phase 2 | |
Recruiting |
NCT05726032 -
Empagliflozin in Patients With Cirrhosis and Ascites
|
Phase 2 | |
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Recruiting |
NCT02331745 -
RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure
|
Phase 4 | |
Not yet recruiting |
NCT01961440 -
Prognosis Scoring System for Acute-on-Chronic Liver Failure
|
N/A | |
Active, not recruiting |
NCT01221454 -
Allogenic Bone Marrow Stem Cell Transplantation in Liver Failure
|
Phase 2 | |
Completed |
NCT00772148 -
Pharmacokinetics of LCP-Tacro™ Once Daily and Prograf® Twice A Day in Adult De Novo Liver Transplant Patients
|
Phase 2 | |
Completed |
NCT05592106 -
Gd-EOB-DTPA-enhanced T1 Map for Predicting Postoperative Liver Failure
|
||
Not yet recruiting |
NCT06014320 -
Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
|
||
Recruiting |
NCT04221672 -
The Effect of Terlipressin on Recovery of Liver Function After Hepatectomy
|
Phase 3 |