Evaluation of the Relationship Between Postoperative Cognitive Dysfunction and Brain Injury Biomarkers In Geriatric Urologic Oncology Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Addenbrooke cognitive examination at the day before surgery.
研究概览
简要总结
Postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. Postoperative cognitive complications are also quite common in extensive oncological surgeries. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers [S100 β, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)].
详细描述
The incidence of POCD changes by age group, type of surgery, testing neuropsychological tests, timing of tests, and the method used for diagnosis. In non-cardiac surgery over the age of 60; the incidence of POCD was 26% in the postoperative 1st week and 10% in the postoperative 3rd month. Although old age is an important risk factor, POCD incidence of up to 36.6% has been reported in a younger period. Major cancer surgery is an important risk factor for development of POCD.
Numerous biomarkers such as; S100β, NSE, Human IL-6, HMGB-1 protein; have been evaluated in studies to determine the diagnosis, prognosis, stage and treatment of POCD.
In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers. (S100β, NSE, Human IL-6 and HMGB-1 protein).The hypothesis of our study is that postoperative brain injury and inflammatory markers (S100β, NSE, Human IL-6 and HMGB-1 protein) will be higher in patients who develop POCD compared to patients who do not develop POCD in geriatric urologic oncology surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 65 who are planned to undergo major urooncological surgery.
排除标准
- •Patients who refuse to participate in the study.
- •Patients with severe hearing-vision problems.
- •Patients with serious neurological-psychiatric disorders.
- •Patients with language barrier.
- •Patients with missing in any interventions.
- •Patients with blood samples that are not suitable for the ELISA.
结局指标
主要结局
Addenbrooke cognitive examination at the day before surgery.
时间窗: The day before surgery.
Test score is between 0-100. 100 is the best point and 0 is the worst point in the test. The test has five cognitive domains including attention, memory, language, visuospatial function, and verbal fluency. Patients who score less than 88 in preoperative tests will be diagnosed with mild cognitive impairment.
Human Neuron Specific Enolase (h-NSE) (ng/mL)
时间窗: Change from baseline serum concentration of h-NSE at 6 hours
h-NSE concentration is determined by an enzyme-linked immunosorbent assay kit.
S 100β (pg/mL)
时间窗: Change from baseline serum concentration of S 100 β at 6 hours
Blood S 100β concentration is determined by an enzyme-linked immunosorbent assay kit.
Interleukine-6 (IL-6) (pg/mL)
时间窗: Change from baseline serum concentration of IL-6 at 6 hours
Blood IL-6 concentration is determined by an enzyme-linked immunosorbent assay kit.
Addenbrooke cognitive examination at seventh day after surgery.
时间窗: The seventh day after surgery.
POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.
Addenbrooke cognitive examination at third months after surgery.
时间窗: The third months after surgery.
POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores.
High Mobility Group Box1 Protein (HMGB1) (ng/mL)
时间窗: Change from baseline serum concentration of HMGB1 at 6 hours
HMGB1 concentration is determined by an enzyme-linked immunosorbent assay kit.
次要结局
- Cerebral oxygenation(During surgery)
- Overall postoperative complications(Up to postoperative three months.)
- Postoperative delirium(Up to postoperative day one)
研究者
Meltem Savran Karadeniz
Associate Professor
Istanbul University