Donor Site ComplicationNCT04422925
s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium
An observational study of Donor Site Complication and Delirium, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Donor Site Complication, Delirium, Uremic Encephalopathy
- What is being tested?
- Living Donor Hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients' demographic data (age, gender, weight, height), accompanying diseases, ASA classification, main etiology, preoperative serums taken in the preoperative period; serum sodium, potassium, ammonium, total bilirubin, ALT, AST, albumin, alkaline phosphatase, INR, creatinine, and BUN shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, first measured central venous pressure, volume replacement therapy, blood component transfusion, the total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded. Besides, the cognitive functions of the patients and blood samples for mentioned values will be evaluated in the preoperative and postoperative periods.
Who may be able to join
- Patients who are admitted as a donor who will undergo living donor hepatectomy operation by Akdeniz University Faculty of Medicine Organ Transplant Center and planned to have a donor right hepatectomy operation
- Patients who have read and accepted the detailed informed consent form
Who cannot join
- Failure to supply routine blood sampling during follow-up
- Having major complications after surgery (pulmonary embolization, sepsis, etc.)
- Individuals with mental health disorders detected by the organ transplantation committee in the preoperative period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation
Antalya, 07059
About this study
Official title: In Living Donor Hepatectomy Cases, the Preoperative and Postoperative Relationship Between s100β, NSE and GFAP Levels and Postoperative Delirium
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.
Read the detailed 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.
- Being tested
- Living Donor Hepatectomy
- Keywords
- donor living hepatectomy, s100β, neuron specific enolase, glial fibrillary acidic protein, delirium
- Medical subject headings
- Delirium, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Donor HepatectomyProcedure or surgery
On living donor hepatectomy (preoperative), the first following day of surgery, 3rd day, and 7th day, blood will be taken for the measurement of S100β, NSE, and GFAP levels in the postoperative period. The plasma of the blood taken will be separated and stored at -800C. Values will be measured by the ELISA method. During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of serum s100β
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze S100β serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Measured: 2 years
Assessment of serum NSE
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze NSE serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Measured: 2 years
Assessment of serum GFAP
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze GFAP serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Measured: 2 years
Assessment of serum cognitive functions and delirium status
During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2019
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Dinc, Akdeniz University
- Investigators
- Bora Di̇nc, MD, Assist. Prof., Study director, Akdeniz University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422925
- Sponsor's protocol ID
- s100β, NSE n GFAP in LDH
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Living Donor Hepatectomy Cases, the Preoperative and Postoperative Relationship Between s100β, NSE and GFAP Levels and Postoperative Delirium
- ClinicalTrials.gov ID
- NCT04422925
- Acronym / sponsor ID
- s100β, NSE n GFAP in LDH
- Keywords
- donor living hepatectomy, s100β, neuron specific enolase, glial fibrillary acidic protein, delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' demographic data (age, gender, weight, height), accompanying diseases, ASA classification, main etiology, preoperative serums taken in the preoperative period; serum sodium, potassium, ammonium, total bilirubin, ALT, AST, albumin, alkaline phosphatase, INR, creatinine, and BUN shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, first measured central venous pressure, volume replacement therapy, blood component transfusion, the total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded. Besides, the cognitive functions of the patients and blood samples for mentioned values will be evaluated in the preoperative and postoperative periods.
Key inclusion criteria (2 listed)
- Patients who are admitted as a donor who will undergo living donor hepatectomy operation by Akdeniz University Faculty of Medicine Organ Transplant Center and planned to have a donor right hepatectomy operation
- Patients who have read and accepted the detailed informed consent form
Key exclusion criteria (3 listed)
- Failure to supply routine blood sampling during follow-up
- Having major complications after surgery (pulmonary embolization, sepsis, etc.)
- Individuals with mental health disorders detected by the organ transplantation committee in the preoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living Donor HepatectomyOn living donor hepatectomy (preoperative), the first following day of surgery, 3rd day, and 7th day, blood will be taken for the measurement of S100β, NSE, and GFAP levels in the postoperative period. The plasma of the blood taken will be separated and stored at -800C. Values will be measured by the ELISA method. During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point. | Procedure or surgery | – |
Primary outcome
Assessment of serum s100β
Time frame: 2 years
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze S100β serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Assessment of serum NSE
Time frame: 2 years
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze NSE serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Assessment of serum GFAP
Time frame: 2 years
Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze GFAP serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.
Assessment of serum cognitive functions and delirium status
Time frame: 2 years
During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bora Di̇nc, MD, Assist. Prof. study director
Akdeniz University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donor Site Complication and Delirium, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of serum s100β (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.