Study of Peripheral Tissue Oxygenation in End-stage Liver Disease Patients During Liver Transplantation

October 1, 2016 updated by: Achal Dhir, Lawson Health Research Institute

Study of Peripheral Microcirculatory Dysfunction in End-stage Liver Disease Patients During Liver Transplantation Using Near Infrared Spectroscopy

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.

Study Overview

Status

Withdrawn

Detailed Description

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

  1. Demographic data: a)age, b)sex, c)diagnosis, d)Model of End-stage Liver Disease (MELD) score, Body Mass Index (BMI)
  2. Clinical parameter : the investigator will collect clinical data including VOT parameters (from above), hemodynamics parameter, chemical parameters and medications used in specific time frame :

    • time frame

      1. pre-operative (for base line data)
      2. pre-anhepatic phase (15 min. before the inferior vena cava (IVC) clamps)
      3. anhepatic phase (30 min. after the IVC clamps),
      4. reperfusion phase (30 min. after the release the IVC clamps),
      5. immediately post operation (at the skin closure)
    • hemodynamics : SpO2 (Pulse oxygen saturation), MAP (mean arterial pressure), HR (heart rate), CVP (Central venous pressure), PAP (Pulmonary artery pressure), CI (Cardiac output index), PCWP (Pulmonary artery wedge pressure), SVRI (Systemic vascular resistance index), PVRI (Pulmonary vascular resistance index), temperature
    • chemical : Hb, Platelets, INR (international normalized ratio) (PT : Prothrombin time), PTT (partial thromboplastin time), Lactate, base excess
    • Medications : Volatile agents, Vasopressors (Concentration at recorded time points)

Then we will compare the dynamic changes of StO2 parameters in different time points (as mentioned) and compare to the hemodynamics and chemical parameters.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University Hospital, London Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients suffering from end-stage liver disease scheduled for liver transplantation

Description

Inclusion Criteria:

  • Adult patients suffering from end-stage liver disease scheduled for liver transplantation.

Exclusion Criteria:

  • Patients with known peripheral vascular disease
  • Patients receiving Oxygen therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
the end-stage liver disease patients
the end-stage liver disease scheduled for liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative for baseline data, intraoperative (during different phase of liver transplantation) and finish data record at skin closure time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Achal Dhir, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 1, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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