Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in renal functional reserve after laparoscopic deroofing
研究概览
简要总结
Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.
详细描述
Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated GFR >30 mL/min/1.73m2
- •Subjects who signed informed consent forms
排除标准
- •Allergy to iothalamate, shellfish or iodine
- •Use of metformin or amiodarone
- •Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- •Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- •Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- •Inadequate intravenous access
- •Severe anemia (Hct <21%)
- •Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- •History of contrast-induced nephropathy
- •Hyperthyroidism
- •Pheochromocytoma
- •Sickle cell disease
- •Urinary retention or incontinence
- •Status post organ transplant
- •Pregnancy or active breast feeding
- •Cognitive impairment with inability to give consent
- •Institutionalized status
研究组 & 干预措施
endophytic group
participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
干预措施: Laparoscopic deroofing (Procedure)
endophytic group
participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
干预措施: 100 g of amino acids supplementation (Drug)
exophytic group
participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
干预措施: Laparoscopic deroofing (Procedure)
exophytic group
participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.
干预措施: 100 g of amino acids supplementation (Drug)
结局指标
主要结局
Change in renal functional reserve after laparoscopic deroofing
时间窗: 1 month after surgery.
1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.
次要结局
未报告次要终点
研究者
ou tongwen
Head of Urology
Xuanwu Hospital, Beijing