MedDataX Logo

Liver Transplant Does it Affect the Brain

NCT ID: NCT04368052

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-27

Study Completion Date

2020-01-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Liver transplantation Neuronal damage Brain Biochemical marker Postoperative Cognitive Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observation

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.

Group Type OTHER

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ege University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa Nuri Deniz

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ebru Sezer, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ege University Medical Faculty, Department of Medical Biochemistry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ege University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

27042020

Identifier Type: -

Identifier Source: org_study_id