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临床试验/NCT04961866
NCT04961866已完成不适用

Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)

Minia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
hand grip strength

研究概览

简要总结

Sixty patients who need Parenteral nutrition 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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for> 48 hs.

排除标准

  • •- Hepatic patients Renal patients Age <18 years

研究组 & 干预措施

Group A

Active Comparator

patients received 1 g/ kg of protein

干预措施: parenteral protein 1 g/kg (Dietary Supplement)

Group B

Active Comparator

patients received 2 g/ kg of protein

干预措施: Parenteral nutrition 2 g/kg (Dietary Supplement)

结局指标

主要结局

hand grip strength

时间窗: 10 days

hand grip strength using dynamometer

次要结局

  • nitrogen balances(10 days)
  • ultrasound guided muscle thickness(10 days)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karim Naser Hasan

assisstant lecturer

Minia University

研究点 (1)

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