Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+2

+ Liver Diseases

+ Liver Failure

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2013
See protocol details

Summary

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: October 4, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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 Disease (MELD) score, Body Mass Index (BMI) 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 pre-operative (for base line data) pre-anhepatic phase (15 min. before the inferior vena cava (IVC) clamps) anhepatic phase (30 min. after the IVC clamps), reperfusion phase (30 min. after the release the IVC clamps), 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.

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: October 4, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesLiver DiseasesLiver FailureHepatic InsufficiencyEnd Stage Liver Disease

Criteria

1 inclusion criteria required to participate
Adult patients suffering from end-stage liver disease scheduled for liver transplantation

2 exclusion criteria prevent from participating
Patients receiving Oxygen therapy

Patients with known peripheral vascular disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital, London Health Science Center

London, CanadaOpen University Hospital, London Health Science Center in Google Maps
SuspendedOne Study Center