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临床试验/NCT06408597
NCT06408597进行中(未招募)不适用

The Use of Intra-operative Mannitol Versus Nitroglycerin to Prevent Post-operative Acute Kidney Injury in Patients Undergoing Robotic-assisted Radical Prostatectomy or Cystectomy: A Randomized Controlled Trial.

Nazmy Edward Seif1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月12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)
发起方
入组人数
90
试验地点
1
主要终点
Cystatin C level

研究概览

简要总结

Laparoscopic and minimally-invasive robotic access has transformed the delivery of urological surgery. While associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function, these techniques have also been associated with morbidity such as reduced renal blood flow and post-operative renal dysfunction. The mechanisms leading to these renal effects complex are multifactorial, and have not been fully elucidated. However they are likely to include direct effects from raised intra-abdominal pressure, and indirect effects secondary to carbon dioxide absorption, neuroendocrine factors and tissue damage from oxidative stress. It is well documented that pneumoperitoneum places profound stress on the cardiovascular, respiratory and gastrointestinal systems; it also places strain on the renal system.

During robotic surgery, continuous pneumoperitoneum and continuous rising of intra-abdominal pressure causes transient oliguria. Moreover, kidney function, estimated by the GFR, deteriorates during elevated intra abdominal pressure (IAP), and most of the studies identified decrease in renal blood flow (RBF) and renal cortical perfusion.

Studies conducted to assess the contribution of the nitric oxide (NO) system to the renal hemodynamic/function alterations during pneumoperitoneum, concluded that these adverse effects are probably related to interference with the NO system, and could be partially ameliorated by pretreatment with nitroglycerine.

Mannitol is an osmotic diuretic and a renal vasodilator that promotes tubular flow, prevents intratubular cast formation, decreases postischemic cellular swelling, and might serve as a free radical scavenger. Mannitol has traditionally been administered before renal surgeries to minimize perioperative renal dysfunction according to preclinical animal studies and clinical experience with renal transplantation. However, high-level clinical data in support of this belief are not available.

The aim of this study is to characterize the effects of increased intra-abdominal pressure on renal perfusion and function in cases undergoing robotic lower tract urologic surgeries, and to assess the contribution of either mannitol or nitroglycerin infusion to the renal hemodynamic/function alterations during pneumoperitoneum.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA class I - III
  • •Normal renal functions or Mild renal disease (GFR < 60 ml/min &/or presence of albuminuria > 30 mg/dl)

排除标准

  • •BMI > 40
  • •Previous renal surgery
  • •Moderate (GFR 30 - 59 mg/dl) & severe (GFR 15 - 29 mg/dl) renal impairment
  • •Decompensated cardiac disease: New York Heart Association (NYHA) class 3 or 4
  • •Allergy to mannitol or nitroglycerin

研究组 & 干预措施

Nitroglycerin group

Experimental

Nitroglycerin Infusion group

干预措施: Nitroglycerin Infusion (Procedure)

Control group

Active Comparator

Standard Fluid Therapy group

干预措施: Fluid Regimen (Procedure)

Nitroglycerin group

Experimental

Nitroglycerin Infusion group

干预措施: Fluid Regimen (Procedure)

Mannitol group

Experimental

Mannitol Infusion group

干预措施: Mannitol Infusion (Procedure)

Mannitol group

Experimental

Mannitol Infusion group

干预措施: Fluid Regimen (Procedure)

结局指标

主要结局

Cystatin C level

时间窗: 24 hours

Serum Cystatin C value in mg/l

次要结局

未报告次要终点

研究者

发起方
Nazmy Edward Seif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nazmy Edward Seif

Clinical Professor

Cairo University

研究点 (1)

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