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

NCT04122027 | Unknown DMC

• 1 other identifier: UW 18-321
• Study Type: interventional
• Target: 158
• Locations: 2 countries
• Sites: 2

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.

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (1)

• Duration of confusion as assessed by the Confusion Assessment method

  To assess patients experience of development of delirium

  48 hours after liver transplant

Secondary Outcomes (2)

• The time taken for MOCA to return to baseline

  10 days after liver transplant

• Other complications unrelated to neurological deficit according to Clavien-Dino Classification.

  2 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients undergoing liver transplantation without regional cerebral oxygenation monitoring using a cerebral oximeter.

Other: Cerebral oximeter

Intervention

ACTIVE COMPARATOR

Patients undergoing liver transplantation with regional cerebral oxygenation monitoring using a cerebral oximeter.

Other: Cerebral oximeter

Interventions

Cerebral oximeter OTHER

Near infra-red spectroscopy, NIRS

Control; Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Queen Mary Hospital

Hong Kong, China

RECRUITING

Queen mary Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Kenneth Chok, MBBS, MS, FRCS, FCSHK, FHKAM

CONTACT

22553025; chok6275@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: July 30, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

HK (1); CN (1)