Liver Transplant Does it Affect the Brain

Not Applicable

Completed

• Conditions: Neuron Specific Enolase; Glial Fibrillary Acidic Protein; Brain Damage; Postoperative Cognitive Dysfunction
• Interventions: Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein

• Registration Number: NCT04368052
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-27
• Primary Completion: 2019-10-11
• Study Completion: 2020-01-03
• Status Verified: 2020-04
• Study First Submitted: 2020-04-26
• Study First Submitted QC: 2020-04-28
• Last Update Submitted: 2020-04-28
• Study First Posted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Observation	Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein	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.

Primary Outcome Measures

Name	Time	Method
Neuron specific enolase (NSE)	Throughout the operation	NSE should not be evaluated as a marker of brain damage in liver transplantations.

Secondary Outcome Measures

Name	Time	Method
S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)	Throughout the operation	Neuroprotective approach protects 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.

Trial Locations

Locations (1)

Ege University Faculty of Medicine; 🇹🇷 İzmir, Turkey