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A Prospective Randomized Controlled Trial on the Use of Cerebral Oximetry in Adult Chinese Patients Undergoing Liver Transplantation (LT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122027
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Kenneth Siu-Ho Chok, The University of Hong Kong

Brief Summary:
Liver transplantation (LT) is a life-saving procedure for patients with end-stage liver diseases. Although with continuous advancement in technology, it remains a high-risk operation. The goal of LT is not only ensure survival of the patients but also to restore them back to their pre-morbid state with a good quality of life. Neurological sequelae can have major impact on postoperative outcomes after LT and yet the reported literature is scarce. Studies from Western countries showed some evidence on the use of cerebral oximtery in cardiac surgery to prevent neurological mishaps. LT shares similar intra-operative fluctuation of the haemodynamices as in cardiac surgery, causing disturbances in regional cerebral oxygenation and theorectically cerebral oximetry should be of great value as well in LT surgery. Data from a large randomised controlled trial is lacking from the current literatures. We therefore propose a prospective randomized controlled trial on the use of this device in adult LT and see whether its use could reduce neurological mishaps.

Condition or disease Intervention/treatment Phase
Liver Failure Other: Cerebral oximeter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Use of Cerebral Oximetry In Adult Chinese Patients For Liver Transplantation
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Patients undergoing liver transplantation without regional cerebral oxygenation monitoring using a cerebral oximeter.
Other: Cerebral oximeter
Near infra-red spectroscopy, NIRS

Active Comparator: Intervention
Patients undergoing liver transplantation with regional cerebral oxygenation monitoring using a cerebral oximeter.
Other: Cerebral oximeter
Near infra-red spectroscopy, NIRS




Primary Outcome Measures :
  1. Duration of confusion as assessed by the Confusion Assessment method [ Time Frame: 48 hours after liver transplant ]
    To assess patients experience of development of delirium


Secondary Outcome Measures :
  1. The time taken for MOCA to return to baseline [ Time Frame: 10 days after liver transplant ]
    To assess the time patients required to return health conditions within 10 days after surgery

  2. Other complications unrelated to neurological deficit according to Clavien-Dino Classification. [ Time Frame: 2 years ]
    To monitor any other complications developed by patients after liver transplant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to get informed consent by patient
  • Patients undergo DDLT or LDLT at Department of Surgery, Liver Transplant Centre, The University of Hong Kong, Queen Mary Hospital
  • Ethnicity is Chinese

Exclusion Criteria:

  • Refusal of consent by patient
  • Pre-existing neurological damage, history of seizures and on antidepressants
  • Skin conditions over forehead that precludes the application of sensors of equipment
  • Ethnicity is not Chinese

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): NCT04122027


Contacts
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Contact: Kenneth Chok, MBBS, MS, FRCS, FCSHK, FHKAM 22553025 ext 085222554848 chok6275@hku.hk

Locations
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China
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Kenneth Siu-Ho Chok    852 22553025 ext 085222554848    chok6275@hku.hk   
Hong Kong
Queen mary Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong

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Responsible Party: Dr. Kenneth Siu-Ho Chok, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04122027    
Other Study ID Numbers: UW 18-321
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases