Liver Failure Clinical Trial
— LTOfficial title:
Use of Cerebral Oximetry In Adult Chinese Patients For Liver Transplantation
NCT number | NCT04122027 |
Other study ID # | UW 18-321 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2018 |
Est. completion date | May 31, 2020 |
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.
Status | Recruiting |
Enrollment | 158 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Queen Mary Hospital | Hong Kong | |
Hong Kong | Queen mary Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China, Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of confusion as assessed by the Confusion Assessment method | To assess patients experience of development of delirium | 48 hours after liver transplant | |
Secondary | The time taken for MOCA to return to baseline | To assess the time patients required to return health conditions within 10 days after surgery | 10 days after liver transplant | |
Secondary | Other complications unrelated to neurological deficit according to Clavien-Dino Classification. | To monitor any other complications developed by patients after liver transplant | 2 years |
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