Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)
研究概览
简要总结
This is Interventional clinical trail will be conducted in Internationale hospital ICU s patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission within 30 days.
详细描述
STUDY DESIGN This is the prospective interventional randomized controlled trial in which effect of protein prescription on UUN and clinical outcome of critically ill patients enroll in the study will compare The NUTRIC scores will be calculated manually, based on data from the medical records of critically ill patients.This trail will be conducted in three stages.
In Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1) Interventional Group None Interventional Group Phase III: Follow the patient for 28 days after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs, MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months.
STATISTICAL METHODS:
Descriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. Z test will be use for the comparison of quantitative variables and Chi square test will be use for categorical data. A NOVA will be use where applicable
.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill patient with nutritional risk Age >18 years Pt. ICU stay> 48hours
排除标准
- •Patients on ventilator > 72 hours < 48 hours.' stay in ICU Withdrawal of life support within 7 days of randomization
研究组 & 干预措施
1 g per kg body weight per day
Protein will be receive by patients that is 1g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.
Base line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS)
干预措施: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional (Other)
2 g per kg body weight per day
Protein will be receive by patients that is 2g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.
Base line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS)
干预措施: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional (Other)
结局指标
主要结局
Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)
时间窗: for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly
change in nitrogen balance from baseline.
Readmission in hospital within 30 days of discharge.
时间窗: 30 days after discharge
Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio
次要结局
- Sequential Organ Failure Assessment (SOFA Score)(up to 72 hours in ICU stay)
- protein bio markers(up to 72 hours in ICU stay)
研究者
Zainab Bibi
Prinicipal Investigator
Allama Iqbal Open University Islamabad