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临床试验/NCT07669337
NCT07669337进行中(未招募)不适用

Conventional Fluid Management Versus Plethysmography Variability Index-based Goal-directed Fluid Management in Patients Undergoing Transurethral Resection of the Prostate-a Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
58
试验地点
1

研究概览

简要总结

Transurethral resection of the prostate (TURP) is a widely performed surgical procedure for the management of benign prostatic hyperplasia. Because of the constant and frequently undetectable fluid exchange through the open prostatic venous sinuses, it is difficult to determine the precise amount of irrigating fluid absorbed after TURP surgery. Unpredictable intravascular volume changes may result from this. While over-resuscitation raises the risk of fluid overload, pulmonary edema, and cardiac events, under-resuscitation in older individuals can lead to hypotension and decreased organ perfusion. Fluid management in TURP has always depended on traditional techniques that employ clinical evaluations like blood pressure and heart rate monitoring or fixed-volume infusion procedures. By using advanced technologies, goal-directed fluid therapy (GDFT) methods continually monitor and evaluate a patient's physiological status in real time, modifying fluid dosage as necessary. A dynamic method for determining volume status, the plethysmography variability index (PVI) has been studied in numerous clinical settings and has proven reliable in predicting fluid responsiveness and acting as a fluid resuscitation guide

详细描述

Transurethral resection of the prostate (TURP) is a widely performed surgical procedure for the management of benign prostatic hyperplasia, which affects a significant number of elderly men . TURP involves the removal of prostate tissue via the urethra and is associated with potential fluid shifts, blood loss, and hemodynamic instability. Effective fluid management during the procedure is crucial to ensure optimal patient outcomes, minimizing complications such as hypotension, acute kidney injury, and electrolyte imbalances .

Because of the constant and frequently undetectable fluid exchange through the open prostatic venous sinuses, it is difficult to determine the precise amount of irrigating fluid absorbed after TURP surgery. Unpredictable intravascular volume changes may result from this. While over-resuscitation raises the risk of fluid overload, pulmonary edema, and cardiac events, under-resuscitation in older individuals can lead to hypotension and decreased organ perfusion Fluid management in TURP has always depended on traditional techniques that employ clinical evaluations like blood pressure and heart rate monitoring or fixed-volume infusion procedures. Although the goal of these methods is hemodynamic stability, they might not be accurate in dynamically adapting to the specific requirements of each patient, especially when there are large fluid shifts. Furthermore, these approaches frequently overlook the fluctuations in patients' hemodynamic state in real time, which may result in either excessive or insufficient resuscitation By using advanced technologies, goal-directed fluid therapy (GDFT) methods continually monitor and evaluate a patient's physiological status in real time, modifying fluid dosage as necessary. A dynamic method for determining volume status, the plethysmography variability index (PVI) has been studied in numerous clinical settings and has proven reliable in predicting fluid responsiveness and acting as a fluid resuscitation guide .

The PVI has been shown to perform similarly to more invasive and expensive dynamic fluid assessment technologies (such as pulse pressure variation and stroke volume variation) . A small-sized randomized controlled trial (RCT) showed that PVI-directed fluid management reduced the lactate concentrations and improved fluid management in abdominal surgery recipients .

Nevertheless, the clinical outcomes of conventional fluid management with PVI-based GDFT were investigated in previous studies like colorectal surgeries and spine surgeries; we did not find a previous study investigating this strategy in elderly patients undergoing TURP surgery .

This randomized controlled trial (RCT) aims to compare the clinical outcomes of conventional fluid management with PVI-based GDFT in patients undergoing TURP. We hypothesize that PVI-guided fluid management will result in better intraoperative hemodynamic stability, a reduction in postoperative complications, and an overall improvement in patient recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

This randomized controlled trial (RCT) aims to compare the clinical outcomes of conventional fluid management with PVI-based GDFT in patients undergoing TURP. We hypothesize that PVI-guided fluid management will result in better intraoperative hemodynamic stability, a reduction in postoperative complications, and an overall improvement in patient recovery.

入排标准

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

入选标准

  • • Male patients aged from 50 to 80 years Scheduled for elective TURP.
  • ASA Ⅰ, Ⅱ.

排除标准

  • • Cardiac arrhythmias (e.g., atrial fibrillation)
  • Left ventricular ejection fraction <40%
  • Chronic kidney disease (stage ≥ 3)
  • Hepatic dysfunction
  • Peripheral vascular disease
  • Prolonged procedures more than 2 hours or complicated procedures with severe bleeding affecting management (Severe bleeding will be defined as any of the following: a drop in hemoglobin of ≥ 2 g/dl, hemodynamic instability due to blood loss that requires blood transfusion).
  • Patients refuse to share in this study.

研究组 & 干预措施

Conventional Fluid Management.

Active Comparator

Participants will receive conventional intraoperative fluid management according to the study protocol, based on mean arterial pressure (MAP) monitoring and fluid administration as clinically indicated.

干预措施: Conventional Fluid Management (Other)

PVI-Guided Goal-Directed Fluid Manage

Experimental

Participants will receive intraoperative fluid management guided by Plethysmography Variability Index (PVI) measurements according to the study protocol, with fluid administration adjusted based on PVI values and hemodynamic parameters.

干预措施: Plethysmography Variability Index (PVI)-Guided Goal-Directed Fluid Management (Other)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Saeed Toukhy Mohammed

Principal Investigator

Cairo University

研究点 (1)

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