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临床试验/NCT01898897
NCT01898897Unknown不适用

Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury

Iuliu Hatieganu University of Medicine and Pharmacy2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
acute kidney injury

研究概览

简要总结

The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.

详细描述

The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • signed the informed consent without previous renal function alteration respiratory and hemodynamic stability

排除标准

  • refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases

结局指标

主要结局

acute kidney injury

时间窗: 4 days

Acute kidney injury, previously referred as acute renal failure is a serious complication of major surgery. The diagnostic of subclinical alteration of kidney function is possible with the novel biomarkers, such as neutrophil gelatinase associated lipocalin (NGAL). Modified NGAL values can be detected in patients urine and serum at 6 hours from the renal injury. In our study, we assessed the renal function by determining basal creatinine and follow the creatinine values 4 days postoperative. Acute kidney injury (AKI)is defined as a 0.3 mg/ml rise in serum creatinine from baseline, according to the AKIN criteria. NGAL is measured (with ELISA technique) at 6 hours and 12 hours from the induction of the anesthesia. The incidence of AKI will be compared in the different anesthesia techniques for robot assisted urogenital laparoscopic surgery.

次要结局

  • postoperative outcome(10 days)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihaly Orsolya

MD, PhD

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (2)

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