Evaluation of s100β, NSE and GFAP Levels in Renal Transplantation

NCT04042272 | Completed

• 1 other identifier: S100β, NSE n GFAP in RT
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Uremic encephalopathy is an organic brain disorder may be frequently seen in patients with acute or chronic renal failure. Certain neurological symptoms can be found under clinical glomerular filtration rate of 15 ml/minutes. The above mentioned neurological disorders can be due to uremic toxins as well as many other reasons such as metabolic and hemodynamic disturbances, inflammation, or oxidative stress. Most frequent symptoms are impaired consciousness, lethargy, cranial nerve involvement, nystagmus, dysarthria, and even coma and death. Brain tissue may receive damage and some secondary biomarkers may appear in case BUN (Blood Urea Nitrogen) level is \>175 mg/dl together with neuroinflammation. Although hemodialysis is a temporary solution in terms of treatment, these symptoms may be reversible in the long-run with organ transplantation. A rigorous neurological assessment before transplantation is important for identifying the severity and distribution of the neurological disorder as well as defining the abnormalities that are responding to the current treatments and foreseeing potential postoperative prognosis. S100β is excreted by astrocytes in brain damage cases. S100β level rises when brain damage starts, thus it may be used in the prognosis of brain damage in its early period. Neuron-specific enolase (NSE) functions as intracytoplasmic enzyme and serum level rises in neuron damage. Glial fibrillary acidic protein (GFAP), on the other hand, is the intermediary filament cytoskeleton protein found in astrocytes. It has the same root structure with S100β. The purpose of this study is to assess neurological damage by looking at the levels of S100β, NSE and GFAP in patients who underwent kidney transplantation and to analyze the impacts on the prognosis.

Conditions

Kidney Transplant; Complications; Neurologic Manifestations; Uremic Encephalopathy

Keywords

kidney transplantation; s100β; neuron specific enolase; glial fibrillary acidic protein

Outcome Measures

Primary Outcomes (3)

• Assessment of serum s100β

  Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation 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 seventh day and the first month) period to analyze S100β serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.

  2 years

• Assessment of serum NSE

  Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation 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 seventh day and the first month) period to analyze NSE serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.

  2 years

• Assessment of serum GFAP

  Approximately 40 patients planned to have living donor renal transplantation and 40 patients planned to have nephrectomy for kidney donation 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 seventh day and the first month) period to analyze GFAP serum concentrations and neurologic damage of kidney transplantation and nephrectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until plasma separation process.

  2 years

Study Arms (2)

Healthy volunteers

Healthy volunteers group; Kidney donor groups; Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded.

Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)

Living kidney graft recipients

Kidney transplant group; Course of the research: Course of the research: Blood samples from all groups shall be taken for S100β, NSE, and GFAP in the preoperative period, in the operating room and after 1st, 7th day and the first following month in the postoperative period. Mortality and morbidity of the patients shall be recorded. Neurological damage and its effect on prognosis shall be examined within the patients with S100β, NSE, and GFAP. Patients' demographic data, accompanying diseases, American Society of Anesthesiology classification, main etiology, preoperative laboratory values shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, and immunosuppressive drugs are given during the operation shall be recorded.

Diagnostic Test: S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)

Interventions

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

S100β is 10.4 kDa protein. Synthesized with end-feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium-binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction. Glial fibrillary acidic protein (GFAP) is the intermediate filament cell skeleton protein found in astrocytes. It originates from the same root structure as S100β.

Healthy volunteers; Living kidney graft recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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, graft hot and cold ischemia durations, first measured central venous pressure, volume replacement therapy, blood component transfusion, total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded.

You may qualify if:

• End-stage renal failure patients
• Healthy volunteer patients.

You may not qualify if:

• Nonvolunteers
• Active infections
• Oncologic or hematologic diseases
• Cadaver graft recipients
• History with psychoactive medications
• History with a respiratory system or central nervous system disorders
• Severe heart failure

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

s100β, neuron specific enolase and glial fibrillary acidic

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 1, 2019
• Study Start: August 15, 2019
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

TU (1)