Liver Transplant Does it Affect the Brain

NCT04368052 | Completed

• 1 other identifier: 27042020
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Damage; Postoperative Cognitive Dysfunction; Neuron Specific Enolase; Glial Fibrillary Acidic Protein

Keywords

Liver transplantation; Neuronal damage; Brain; Biochemical marker; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Neuron specific enolase (NSE)

  NSE should not be evaluated as a marker of brain damage in liver transplantations.

  Throughout the operation

Secondary Outcomes (1)

• S-100 beta (S100β), and Glial fibrillary acidic protein (GFAP)

  Throughout the operation

Study Arms (1)

Observation

OTHER

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.

Diagnostic Test: Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein

Interventions

Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein DIAGNOSTIC_TEST

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.

Observation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hepatic encephalopathy,
• Neurological disorder
• Psychiatric disorder,

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Injuries; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ebru Sezer, Assoc. Prof.

  Ege University Medical Faculty, Department of Medical Biochemistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: April 29, 2020
• Study Start: February 27, 2018
• Primary Completion: October 11, 2019
• Study Completion: January 3, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)