Liver Transplant Does it Affect the Brain

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

Evaluation of The Association Between Cognitive Dysfunction and Brain Cellular Damage During Liver Transplantations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04368052
• Other study ID #: 27042020
• Status: Completed
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: January 3, 2020

Study information

• Verified date: April 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 3, 2020
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein
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 (S100ß), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuron specific enolase (NSE)	NSE should not be evaluated as a marker of brain damage in liver transplantations.	Throughout the operation
Secondary	S-100 beta (S100ß), and Glial fibrillary acidic protein (GFAP)	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 S100ß level and the significant decrease in GFAP.	Throughout the operation