Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04422925 |
Other study ID # |
s100ß, NSE n GFAP in LDH |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
December 1, 2021 |
Study information
Verified date |
January 2022 |
Source |
Akdeniz University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The post-operative delirium picture is a serious and common complication seen after any major
surgery, including hepatic resection. Patients who will be planned to undergo donor
hepatectomy for liver transplantation will be included in the study. Basic clinical and
demographic information of patients undergoes donor hepatectomy will be recorded before
surgery. The anatomical parameters such as liver volume, medications performed during the
surgery, complications, bleeding amounts, fluids given, blood and blood products, vital signs
during surgery, fluid balance, duration of surgery, recovery length at post-operative period,
complications after surgery, approaches to complications, analgesics and other medications
used, hemogram and other biochemical parameters (electrolytes, albumin, liver frontier tests,
etc.), weight status, vital signs, duration of intensive care, post-operative VAS scores,
drainage and information such as length of stay, length of hospital stay, the healing time of
the wound will also be recorded.
During the hospitalization, the delirium status of the patients will be evaluated with a
delirium evaluation scale by consultant doctor. Blood will be taken for the measurement of
S100β, NSE, and GFAP levels one day before donor hepatectomy and following day of
hepatectomy, 3rd day, and 7th day in the post-operative period. The plasma of the blood taken
will be separated and stored at -80 0C until working. Laboratory values are taken from the
patients before the operation will be recorded over the system. The relationship between the
results obtained and the delirium evaluation scores performed on the days followed will be
evaluated.
This study aims to analyze the delirium incidence and post-operative early S100β, NSE, and
GFAP levels within the first week following the hepatectomy performed in live donors for
liver transplantation.
Description:
The postoperative delirium picture is a serious and common complication seen after any major
surgery, including hepatic resection. Delirium is an acute state of confusion characterized
by impaired consciousness, reduced ability to focus on attention, changes in cognitive
functions, a perceptual disturbance development, and an uncomfortable sleep-wake cycle.
Postoperative delirium has an acute onset and has a fluctuating course. This complication
results in a long recovery period, a longer stay in the intensive care unit, higher
complication rates, extra nursing care, and higher costs. Therefore, appropriate methods are
needed to prevent and treat postoperative delirium.
The pathophysiology of delirium is thought to be due to many reasons. Examined in titles:
Changes in the electrolyte and fluid balance, nutritional imbalance (low serum
protein/albumin level, hypovitaminosis, especially cobalamin deficiencies (B12), folate (B9),
niacin (B3, pellagra), thiamine, age (> 65) and gender (m> f), hyperthermia and hypothermia,
major surgical procedures, endocrine disorders, drug use, anemia, anoxia, hypoxia and low
perfusion/oxygenation states, postoperative pain and painkiller medication, end-organ
failure, social isolation, decreased intellectual stimulation (long-term intensive care
therapy), sleep disorders and changes in the circadian rhythm, metabolic disorders (acidosis,
alkalosis, hyperammonemia, hypersensitivity reactions, glucose, and acid-base disorders,
limitations, and inactivity. Cases are exposed to these predisposing causes.
Postoperative delirium is a type of delirium that is exposed to surgical procedure and
anesthesia, usually seen between the 1st and 3rd days after surgery. Postoperative delirium
can be seen at rates ranging from 9 to 87% depending on the age of the patient and the type
of surgery. Although its etiology is not yet understood, it is probably thought to be
multifactorial.
S100β is secreted by astrocytes in brain damage. S100β rises while brain damage starts, so it
can be used in the diagnosis of early brain damage. Neuron-specific enolase (NSE) acts as an
intracytoplasmic enzyme, and serum levels are increased in neuron damage. The glial fibrillar
acidic protein (GFAP) is the intermediate filament cytoskeleton protein in astrocytes. It
originates from the same root structure as S100β. After hepatectomy, the donor candidates are
exposed to physiological changes that include the central nervous system due to surgical
stress as well as the functional change of the remaining liver tissue. Determining the
increase in serum level of biomarkers specific to the central nervous system mentioned before
the development of cognitive disorders such as delirium may prevent the complications that
may arise during the postoperative period. It also helps to provide treatment in the
postoperative period as well as evaluation.
The aim of this study is to analyze the delirium incidence and postoperative early S100β,
NSE, and GFAP levels within the first week following the hepatectomy performed in living
donors for liver transplantation.