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

This study has been withdrawn prior to enrollment.
(Disposables required for the measurements in short supply and not provided by the company / supplier)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794637
First Posted: February 20, 2013
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Achal Dhir, Lawson Health Research Institute
  Purpose

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.


Condition
End Stage Liver Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Study of Peripheral Microcirculatory Dysfunction in End-stage Liver Disease Patients During Liver Transplantation Using Near Infrared Spectroscopy

Resource links provided by NLM:


Further study details as provided by Achal Dhir, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: February 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
the end-stage liver disease patients
the end-stage liver disease scheduled for liver transplantation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients suffering from end-stage liver disease scheduled for liver transplantation
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794637


Locations
Canada, Ontario
University Hospital, London Health Science Center
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Achal Dhir, MD Western University
  More Information

Publications:

Responsible Party: Achal Dhir, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01794637     History of Changes
Other Study ID Numbers: 103363
First Submitted: January 17, 2013
First Posted: February 20, 2013
Last Update Posted: October 4, 2016
Last Verified: October 2016

Keywords provided by Achal Dhir, Lawson Health Research Institute:
End stage liver disease
Peripheral microcirculatory dysfunction
Liver transplantation
Near infrared spectroscopy

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Liver Extracts
Hematinics