Trial record 15 of 1724 for:    Open Studies | "Liver Diseases"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Achal Dhir, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01794637
First received: January 17, 2013
Last updated: February 19, 2013
Last verified: February 2013
  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 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794637

Contacts
Contact: Achal Dhir, MD 519-685-8500 ext 35314 adhir2@uwo.ca

Locations
Canada, Ontario
University Hospital, London Health Science Center Not yet recruiting
London, Ontario, Canada, N6A 5A5
Contact: Achal Dhir, MD, FRCPC    519-685-8500 ext 33022    adhir2@uwo.ca   
Contact: Aphichat Suphathamwit, MD    519-851-2533    Aphichat.suphathamwit@londonhospitals.ca   
Principal Investigator: Achal Dhir, MD         
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
Study First Received: January 17, 2013
Last Updated: February 19, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014