Effects of Endothelin Receptor Antagonist on Ischemic Kidney Injury During Nephron Sparing Surgery for Renal Mass Excision: Assessment by Ischemia Biomarkers, NGAL, KIM-1
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- RENAL FUNCTION INJURY
研究概览
简要总结
Based on animal studies, it was found that administration of endothelial receptor antagonists before and after renal blood vessels clamp and release results in a significantly reduced renal function injury.
On the basis of these results, we chose to divide the study population into 2 groups: control group that would be treated the standard accepted preventive treatment: intravenous injection of Mannitol, cooling of the kidney surface, compared to the treatment group that in addition would receive pre- and post-operative treatment of endothelial receptor antagonists (Ambrisentan (Volibris (10mg).
To be noticed that the drug is recognized and is given as a primary indication for patients with pulmonary hypertension.
The differences between the renal function and biomarkers for pre- and post-operative renal ischemic injury would be examined in order to disclose if the kidney injury of the treated group was indeed smaller.
This information will enable us to protect the operated kidneys from the ischemic damage, especially in those patients with poor basic renal function.
详细描述
This is a study aimed at examining the protective effect of endothelin antagonism on the ischemic damage the kidney undergoes during partial nephrectomy for kidney lesion removal.
In such procedure, it is common to clamp the kidney blood vessels in order to eliminate blood flow in the surgical field that will enable clear visibility to differentiate the tumor tissue from the normally kidney parenchyma.
Later, after removing the tumor lesion and suturing the tumor bed, the blockage is released and the renal blood flow returns.
The blockage itself and its release causes damage to the kidney tissue that is usually reduced by the kidney's cooling (through ice crystals)and as well as intravenous injection of mannitol.
In this study, patients were divided into 2 groups randomly, assigned the receipt in the order of recruitment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a single kidney lesion who undergo Contrast enhancement (by CT scan)
- •Normal contra-lateral kidney as illustrated by imaging tests
- •Patients eligible for anesthesia and surgery
排除标准
- •Patients with chronic kidney infections
- •Blood clot disorders
- •End-stage renal failure
- •Patients sensitive to the study drug
- •Patients with cardiac heart failure, EF <40%
- •Patients with hyperkalemia
- •Patients with systolic blood pressure under 90 mmHg
研究组 & 干预措施
Treated group
Tab. Volibris 10mg given once a day for 5 days, starting 48 hours before surgery (in addition for the standard treatment for partial nephrectomy)
干预措施: Ambrisentan 10 MG (Drug)
结局指标
主要结局
RENAL FUNCTION INJURY
时间窗: 2 YEARS
quantified by serum CRE, KIM-1,NGAL and urine markers KIM-1 NGAL
次要结局
未报告次要终点
研究者
Ofir. Avitan
Dr. Avitan Ofir
Bnai Zion Medical Center