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临床试验/NCT06274125
NCT06274125招募中不适用

The Assessment of Kidney Damage Using NGAL Measurements in Patients Undergoing Robotic Radical Prostatectomy

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery.

研究概览

简要总结

The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery.

详细描述

The main objective of this study is to evaluate whether blood NGAL measurement provides superiority over sCr and BUN tests in early diagnosis for assessing renal function in patients undergoing robotic urological surgery.

The secondary objective of the study is to evaluate the relationship between AKI development and monitored parameters such as age, BMI, comorbidities, ASA, OAB (overactive bladder), mean arterial pressure, intraabdominal pressure, surgical duration, urea and creatinine levels.

After obtaining ethical approval from the Ministry of Health Ankara City Hospital Oncology Operating Room, a total of 55 patients between the ages of 18-80, ASA 1-3, who will undergo general anesthesia under elective conditions will be included in this prospective observational study.

During the preoperative period, patients will be evaluated and provided with written informed consent. Before being taken to the operating room, patients' age, gender, weight, height, body mass index (BMI), comorbidities, regular medication use, ASA classification, hemodynamic values and laboratory values will be recorded in the waiting area. Once in the operating room, patients will be monitored according to the standard working protocol of the anesthesia clinic including non-invasive arterial blood pressure monitoring, 3 or 5-channel ECG and pulse oximetry. Additionally, standard preoperative and postoperative biochemical profiles (including hemogram) and urinary NGAL levels will be measured.

During the perioperative period, routine hemodynamic parameters such as heart rate (HR) (beats per minute), systolic arterial blood pressure (SAB) (mmHg), diastolic arterial blood pressure (DAB) (mmHg), mean arterial blood pressure (OAB)(mmHg), peripheral oxygen saturation(SpO2) as well as postoperative laboratory values will be recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • A total of 55 patients, with ASA scores 1-2-3, aged between 18 and 80 years, will be included in the study conducted at the Robotic Surgery operating room of Ankara City Hospital, Ministry of Health, Turkey.

排除标准

  • Individuals who do not have the ability to read, understand, or sign the consent form.
  • Individuals with diagnosed renal disease.
  • Patients who do not wish to participate in the study.
  • Patients classified as ASA-3 or higher.

结局指标

主要结局

The main objective of this study is to evaluate whether blood NGAL measurement has superiority over sCr and BUN tests in terms of early diagnosis for assessing kidney function in patients undergoing robotic urologic surgery.

时间窗: For the evaluation of kidney damage in patients undergoing robotic radical prostatectomy, blood samples will be collected at preoperative and perioperative 2nd and 6th hours to measure NGAL values.

次要结局

  • The relationship between demographic parameters such as age, BMI, comorbidities, and ASA classification will be evaluated in relation to the development of AKI.(For the evaluation of kidney damage in patients undergoing robotic radical prostatectomy, blood samples will be collected at preoperative and perioperative 2nd and 6th hours to measure NGAL values.)
  • The evaluation of the relationship between intraabdominal pressure and the development of AKI.(The relationship between intraabdominal pressure monitoring during surgery and NGAL values obtained at 0, 2, and 6 hours.)
  • The relationship between intraoperative mean arterial pressure (MAP) and NGAL (Neutrophil Gelatinase-Associated Lipocalin) values.(The relationship between intraoperative mean arterial pressure monitoring and NGAL values obtained at 0, 2, and 6 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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