跳至主要内容
临床试验/NCT01251029
NCT01251029Unknown1 期

Ability of N-acetylcysteine to Prevent Deterioration in Renal Functioning in CKD Patients Undergoing Major Surgery Under General Anesthesia

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
试验地点
1
主要终点
parameters of kidney function

研究概览

简要总结

Acute kidney injury (AKI) is one of the most serious and frequent complication of general anesthesia. Patients suffer from chronic kidney diseases (CKD) predispose to develop AKI. CKD patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop AKI.

N-acetylcysteine (NAC), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. NAC has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins.

Present study aimed to explore the efficacy of NAC treatment to prevent deterioration in renal functioning in CKD patients undergoing major surgery under general anesthesia.

Study will include about 200 CKD (eGFR (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. Patients from each group will randomly divide in two sub-groups (A and B). Subgroup A will receive NAC twice (14-16h and 2h) before surgery and 12h after surgery. Subgroup B will receive placebo (saline).

Markers for kidney function such as eGFR, creatinin, urea, electrolytes, cystatin C, NGAL (Neutrophil Gelatinase-Associated Lipocalin), urine albumin will measure before and after surgery in all patients. An additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.

研究设计

研究类型
Interventional

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

入选标准

  • patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia

排除标准

  • pregnancy
  • single kidney
  • heart failure (NYHA class III-IV)
  • hepatic failure
  • mental diseases

研究组 & 干预措施

sugar pil and saline

Experimental

干预措施: N-acetylcysteine (Drug)

sugar pil and saline

Experimental

干预措施: Siran (N-acetylcysteine) (Drug)

结局指标

主要结局

parameters of kidney function

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验