Effects of Parenteral Protein Concentrations in Critically Ill Patients
Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)
研究概览
地位
详细说明
In this study after obtaining approval from our hospital ethics committee, a written informed consent will be obtained from patient's next of kin.
Sixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.
Inclusion criteria:
Age: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Exclusion criteria:
Pregnant female Hepatic patients Renal patients Age <18 years
Technique of the study :
60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided according to the protein delivery into two groups.
Group A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.
Group B, those patients will receive parenteral proteins in a dose of 2g/kg /day The nutrition will be delivered through a central line and using separate bottles technique ,because of the lack of a compounding unit and commercial bags in our hospital, After exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40 Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and corrected regularly in every patient
The two groups will be compared as regarding the following :
hand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps muscle thickness Nitrogen balances
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Minya、埃及、61111
- Karim Naser Hasan
-
-
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:
- Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.
Exclusion Criteria:
- Hepatic patients Renal patients Age <18 years
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:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Group A
patients received 1 g/ kg of protein
|
patients received 1 g/ kg of protein
|
有源比较器:Group B
patients received 2 g/ kg of protein
|
Patients received 2 g/ kg of protein
|
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 |
---|---|---|
hand grip strength
大体时间:10 days
|
hand grip strength using dynamometer
|
10 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
ultrasound guided muscle thickness
大体时间:10 days
|
us guided biceps and forearm muscle thickness
|
10 days
|
nitrogen balances
大体时间:10 days
|
Measurements
|
10 days
|
合作者和调查者
调查人员
- 学习椅:Ibrahim A. Youssif, MD、Minia University
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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.
Hand Muscle Strain的临床试验
-
University of CalgaryCanadian Institutes of Health Research (CIHR); University of Alberta; Epidemiology Coordinating...终止
-
St Vincent's Hospital, SydneyMerck Sharp & Dohme LLC终止人类免疫缺陷病毒 (HIV) | HIV 相关神经认知障碍 (HAND)澳大利亚
-
Bruce BrewViiV Healthcare完全的人类免疫缺陷病毒 (HIV) | HIV 相关神经认知障碍 (HAND)澳大利亚
-
University of Minnesota撤销轻度认知障碍 (MCI) | 肌萎缩侧索硬化症 (ALS) | 路易体痴呆症 (DLB) | 阿尔茨海默病 (AD) | 额颞叶变性 (FTLD) | 帕金森病伴痴呆症 (PDD) | 短暂性癫痫性失忆症 (TEA) | 颞叶癫痫 (TLE) | 脊髓小脑性共济失调 (SCA) | HIV 相关神经认知障碍 (HAND) | 原发性侧索硬化症 (PLS)美国
parenteral protein 1 g/kg的临床试验
-
Spanish Society of Critical Care Medicine and Coronary...招聘中
-
Trinomab Biotech Co., Ltd.TIGERMED AUSTRALIA PTY LIMITED完全的
-
Bristol-Myers Squibb完全的黑色素瘤法国, 加拿大, 美国, 德国, 澳大利亚, 俄罗斯联邦, 西班牙, 意大利, 荷兰, 波兰, 丹麦, 以色列, 英国