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

NCT01794637 | Withdrawn DMC

• 1 other identifier: 103363
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver Disease

Keywords

End stage liver disease; Peripheral microcirculatory dysfunction; Liver transplantation; Near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• the significant changes in StO2 between anhepatic and reperfusion phase of the end-stage liver disease patient undergoing liver transplantation

  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 Outcomes (1)

• dynamic changes in StO2 during liver transplantation with possible correlation with hemodynamic or chemical parameters in different time points

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

Study Arms (1)

the end-stage liver disease patients

the end-stage liver disease scheduled for liver transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

University Hospital, London Health Science Center

London, Ontario, N6A 5A5, Canada

Location

Related Publications (12)

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  PMID: 18276031 BACKGROUND

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  PMID: 19912533 BACKGROUND

• Steib A, Freys G, Gohard R, Curzola U, Ravanello J, Lutun P, Boudjema K, Otteni JC. Tissue oxygenation during liver transplantation. Crit Care Med. 1992 Jul;20(7):977-83. doi: 10.1097/00003246-199207000-00013.

  PMID: 1617992 BACKGROUND

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  PMID: 20128030 BACKGROUND

• Shelly MP, Dixon JS, Park GR. The pharmacokinetics of midazolam following orthotopic liver transplantation. Br J Clin Pharmacol. 1989 May;27(5):629-33. doi: 10.1111/j.1365-2125.1989.tb03428.x.

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  PMID: 9265907 BACKGROUND

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Achal Dhir, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: February 20, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

CA (1)