Clinical trial NCT04368052: Liver Transplant Does it Affect the Brain
Official title: Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Damage
Postoperative Cognitive Dysfunction
Neuron Specific Enolase
Glial Fibrillary Acidic Protein
Keywords: Liver transplantation
Neuronal damage
Brain
Biochemical marker
Postoperative Cognitive Dysfunction
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neuronal damage caused by neuroinflammation in patients undergoing major surgery is the most determinant factor of postoperative cognitive disfunction (POCD). Neuronal damage can be detected through the measurement of biochemical markers of brain damage. The aim of this study was to evaluate neuronal damage and its association with POCD during liver transplantations. After the approval of the ethics committee and patient consents, preoperative and postoperative cognitive functions of 33 patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels. As a result, there was no statistically significant difference between preoperative and postoperative MMTs. However, there was a statistically significant decrease in postoperative GFAP and a statistically significant increase in NSE compared to preoperative values. The decrease in S100β level was statistically insignificant. In conclusion, neuroprotective approaches in the investigator's anesthesia protocol protect patients from brain damage during liver transplantation and prevent the development of POCD, which was indicated by the insignificant change in MMT scores and S100β level and the significant decrease in GFAP. Since the significant increase in NSE levels during liver transplantations was deemed to might have been associated with causes other than neuronal damage, NSE should not be evaluated as a marker of brain damage in these operations.


Eligibility criteria: Inclusion Criteria:

* Score of 23 or above on the Mini Mental Test (MMT) conducted in the preparation room prior to the operation,
* No gastrointestinal bleeding in the last 1 month
* No history of neuroactive drug use
* Consented for the study.

Exclusion Criteria:

* Hepatic encephalopathy,
* Neurological disorder
* Psychiatric disorder,

Primary outcomes:
measure: Neuron specific enolase (NSE)
timeFrame: Throughout the operation
Secondary outcomes:
measure: S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)
timeFrame: Throughout the operation
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
affiliation: Ege University Medical Faculty, Department of Medical Biochemistry
name: Ebru Sezer, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: