Clinical Trial: Study of Peripheral Tissue Oxygenation in End-stage Liver Disease Patients During Liver Transplantation
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational [Patient Registry]
Official Title: Study of Peripheral Microcirculatory Dysfunction in End-stage Liver Disease Patients During Liver Transplantation Using Near Infrared Spectroscopy
Brief Summary:
End - stage liver disease can cause many problems to the patients including fatigue, weakness,jaundice, confusion, abdominal pain and distension. Another important problem is the cardiovascular system (heart and blood vessels). There will be the impairment of heart function to pump blood to the distal part of the body. Blood vessels are also affected by the imbalance of chemical agents which are not detoxified by diseased liver, resulting in impairment of oxygen carrying capacity and tissue oxygen exchange. Mechanism of this process is still poorly understood.
This is a study about the peripheral vascular dysfunction by means of vascular occlusion test (VOT). Blood pressure cuff is inflated (to occlude the proximal vessels and induce distal part ischemia), then deflated and observing the distal tissue oxygenation (StO2)change by the probe (Near-infrared spectroscopy : NIRS) at the hand. From our knowledge, there is no study in patients undergoing liver transplantation.
The study investigator would like to observe the change in peripheral tissue oxygenation in different time points during the liver transplantation. We hypothesize that there is a change in microcirculatory function and StO2 in end-stage liver disease patients detected by VOT and NIRS.
Detailed Summary:
End - stage liver disease patients scheduled for liver transplantation will be enrolled. They will receive normal standard of care. The VOT assessment using a non-invasive, integrated research device (InspectraTM StO2 Vascular Occlusion test (VOT) Research Device Hutchinson Corp Minn, MN, USA) and 15 mm Inspectra thenar sensor probe. An integrated blood pressure cuff is placed on the right arm and inflated to a pressure sufficient to produce arterial inflow occlusion (50mmHg above systolic pressure). The cuff remains inflated until a StO2 value of 40% is achieved. During the inflation and deflation, various StO2 parameters are measured and recorded at designed time point.
Specific VOT parameters of interest:
- Baseline StO2 (reflective of perfusion/metabolism ratio)
- Ischemia slope (partly reflective of basal O2 consumption)
- Ischemia area (partly reflective of basal O2 consumption)
- Time till 40% ischemic threshold (partly reflective of basal O2 consumption)
- Recovery slope (biphasic and reflective of shear stress and endothelial vasoreactivity)
- Recovery area (reflective of endothelial vasoreactivity)
- Hyperemia area (reflective of endothelial vasoreactivity and tissue metabolic rate) To determine effect of core versus peripheral temperatures, a conventional skin thermocouple will be placed under adhesive patch used to secure NIRS optodes in position on thenar eminence
Data collection
- Demographic data: a)age, b)sex, c)diagnosis, d)Model of End-stage Liver
Sponsor: Lawson Health Research Institute
Current Primary Outcome: the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation [ Time Frame: compare the change of StO2 during different phase of the liver transplantation (base line, pre-anhepatic phase, anhepatic phase, re-perfusion phase and at skin closure) ]
Our data measured will be included only during the operation and at skin closure can reflect early postoperative period.
Original Primary Outcome: Same as current
Current Secondary Outcome: dynamic changes in StO2 during liver transplantation with possible correlation with hemodynamic or chemical parameters in different time points [ Time Frame: preoperative for baseline data, intraoperative (during different phase of liver transplantation) and finish data record at skin closure time) ]
from previous study indicates that new liver start its metabolic function well right after the vascular connection complete. So, the investigator want to analyze the correlation between the dynamic StO2 changes during operative period
Original Secondary Outcome: Same as current
Information By: Lawson Health Research Institute
Dates:
Date Received: January 17, 2013
Date Started: February 2013
Date Completion:
Last Updated: October 1, 2016
Last Verified: October 2016
