Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Nitrogen Balance
研究概览
简要总结
The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study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
结局指标
主要结局
Nitrogen Balance
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Paul Pencharz
Emeritus Scientist
The Hospital for Sick Children