The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)
2011年8月4日 更新者:Vanderbilt University
We propose to determine the acute metabolic effects of intensive insulin therapy when administered to AKI patients with a particular focus on its effects on protein metabolism.
We hypothesize that the degree of insulin resistance correlates with protein catabolism in critically ill patients with AKI, and that intensive insulin therapy will result in substantial reductions in both whole-body and skeletal muscle protein breakdown thereby improving overall protein balance.
We also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with AKI.
The metabolic response to these interventions will be assessed through stable isotope infusion techniques, allowing for the most precise assessment of protein and energy homeostasis.
研究概览
研究类型
介入性
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults ≥ 18 years of age admitted to the intensive care unit
New onset acute kidney injury (AKI) or AKI superimposed on chronic kidney disease. AKI will be defined as:
- an abrupt (within 48 hours) sustained increase (>24 hours) in serum creatinine of 2X baseline or
- a reduction in urine output (documented oliguria of < 0.5 ml/kg/hr for >12 hours)
- Patients will be recruited for the study within 3-5 days following establishment of AKI
Exclusion Criteria:
- Institutionalized patient
- Unable to obtain consent from subject or legally recognized representative
- Pregnancy
- Patients receiving insulin within 12 hours of the study or patients with known diabetes mellitus.
- Patients receiving immunosuppressive medication including steroids (prednisone or equivalent dose ≥ 5 mg PO QD)
- AKI from urinary tract obstruction or a volume responsive pre-renal state.
- Liver Failure, defined as transaminase levels 3 times above the limit of normal or a total Bilirubin greater than 4 mg/dl.
- Evidence of active bleeding, defined as admission for bleeding (ex. GI bleed, ruptured aneurysm, trauma-related) coupled with an explained or unexplained decrease in hemoglobin of >2 points in the past 24 hours, or Hgb<8/Hct<24
- Ongoing myocardial ischemia or heart failure
- Life expectancy < 48 hours
- Patients without existing central venous access
- Hemodynamically unstable patients requiring active pressor titration, defined as an increase in current pressor dose by >20% or addition of a new pressor within 12 hours of initiating the study.
- History of Phenylketonuria (PKU) or other documented inborn errors of metabolism
- Hypokalemia, defined as a serum potassium of <3.0 mg/dl.
- Uncontrolled seizure disorder, defined as having seizure as a reason for admission, ongoing delirium tremens, or having had a seizure within 1 month of the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:1个
|
administration of a primed continuous infusion of human regular insulin at a rate of 2.0 mU/kg/min while maintaining the plasma glucose level at 100 mg/dl via adjusting a variable infusion of 50% dextrose (i.e., a hyperinsulinemic euglycemic blood glucose clamp); duration of 3 hours; performed concomitantly with amino acid supplementation
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
A change in whole body and muscle protein breakdown during amino acid supplementation with insulin versus baseline
大体时间:6 hours
|
6 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Alp Ikizler, MD、Vanderbilt University Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年2月1日
初级完成 (实际的)
2008年11月1日
研究完成 (实际的)
2008年11月1日
研究注册日期
首次提交
2007年12月18日
首先提交符合 QC 标准的
2008年1月1日
首次发布 (估计)
2008年1月14日
研究记录更新
最后更新发布 (估计)
2011年8月5日
上次提交的符合 QC 标准的更新
2011年8月4日
最后验证
2011年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
human regular insulin的临床试验
-
Arash Asher, MDVoxxLife招聘中
-
Imperial College LondonCambridge University Hospitals NHS Foundation Trust; University of Edinburgh; University of Manchester 和其他合作者终止
-
University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的
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University of ConnecticutUnited States Department of Defense; AMP Human; Park City, UT完全的