Nitrogen Balance in Infants After Post Cardiothoracic Surgery
Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
研究概览
地位
条件
详细说明
Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay.
The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5V 1B2
- The Hospital for Sick Children
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Clinical decision to initiate parenteral nutrition based on determination by medical team
- Gestational age ≥ 35 weeks
- Birth weight ≥ 2000 grams
- Indwelling urinary catheters for urine collection
- Central venous access for parenteral nutrition
Exclusion Criteria:
- Chromosomal abnormalities known to effect protein metabolism
- Hepatic failure defined as ALT and AST > 500 UL with an INR > 2.5, not accounted for by therapeutic anticoagulation
- Renal failure defined as creatinine 2x the upper limit of normal for age.
- Sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics
- Excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study
- Requiring Extra Corporeal Membrane Oxygenation (ECMO) support
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：控制组
|
Protein delivery of 1.5 g/kg/day.
|
|
实验性的：干预组1
|
protein delivery of 2.2g/kg/day
|
|
实验性的：干预组2
|
protein delivery of 3.0 g/kg/day
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nitrogen Balance
大体时间：From 0-84 hours
|
After an initial adaptation period of approximately 12 hours receiving parenteral nutrition the first 24-hour urine collection for nitrogen balance will be started; following this two successive 24-hour urine collections will be performed in order to obtain a three-day collection for nitrogen balance analyses.
|
From 0-84 hours
|
合作者和调查者
调查人员
- 首席研究员：Paul B Pencharz, MD、The Hospital for Sick Children, Toronto, Canada
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
Standard protein delivery的临床试验
-
Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
-
Compedica IncProfessional Education and Research Institute完全的
-
Integra LifeSciences CorporationIntegrium终止
-
Cishan Hospital, Ministry of Health and Welfare完全的