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临床试验/NCT02655081
NCT02655081已完成2 期

Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
48
试验地点
2
主要终点
Safety, tolerability and adherence to supplementation regimen."

研究概览

简要总结

To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. The investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. Secondary outcome measures will include differences in length of stay and complication rate between groups.

详细描述

The purpose of this study is to investigate the use of a high-arginine protein supplement prior to surgery for patients undergoing radical cystectomy for treatment of bladder cancer. As many as 50% of patients who undergo radical cystectomy experience a postoperative complication, and poor preoperative nutritional status is known to increase the risk of complications. Preoperative use of a high-arginine protein shake has been shown to reduce the risk of postoperative complications for patients undergoing surgery for colon cancer, and this study seeks to determine whether this is also true for patients undergoing radical cystectomy for bladder cancer.

Subjects will drink four protein shakes (Nestle Impact AR) per day for 5-7 days prior to radical cystectomy. Shakes will be provided to patients free of charge. On the date of surgery, subjects will turn in a log of shake consumption. Surgery will then proceed in typical fashion, and no changes will be made to surgery or postoperative care. Clinical outcomes for the first 90 postoperative days will be collected. Patient outcomes will be compared to those of contemporary controls who do not undergo supervised nutritional supplementation. Primary study outcome is to assess safety, tolerability and adherence to supplementation regimen. Secondary outcomes include differences in complication rates and length of postoperative hospital stay between groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Any adult patient seen at one of the aforementioned UPMC facilities who carries a diagnosis of bladder cancer and is considered a candidate for radical cystectomy for treatment.

排除标准

  • Minors < 18 years of age, patients not considered surgical candidates, patients who do not go on to undergo radical cystectomy. Patients with Glomerular Filtration Rate (GFR) < 30 will also be excluded in an attempt to limit protein intake of patients with Stage IV and V Chronic Kidney Disease. Diabetic patients will be allowed to participate.

结局指标

主要结局

Safety, tolerability and adherence to supplementation regimen."

时间窗: 4 months

Investigator will report on any adverse events from supplementation as well as patient adherence to regimen.

次要结局

  • Incidence of 90-day overall and infectious complication rates. I(4 months)
  • Length of hospital stay between study group and control group(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatum Tarin, MD

Clinical Professor

University of Pittsburgh

研究点 (2)

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