The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,329
- 试验地点
- 126
- 主要终点
- Time to discharge alive from hospital
研究概览
简要总结
The investigator will investigate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual protein/amino acid dosing (≤1.2 g/kg/d) on clinical outcomes in nutritionally high risk ill patients.
详细描述
The EFFORT Study is a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit (ICU). We anticipate over 100 sites participating internationally, with each site enrolling a minimum of 30 patients. Patients will be randomized to 1 of 2 treatment groups: a usual prescription (≤1.2 g/kg/d) or a higher prescription (≥2.2 g/kg/d) of protein. Other than the protein amount the patient is randomized to the remainder of care provided to randomized patient will be at the discretion of ICU providers.
In both groups, targets will be achieved through any combination of enteral nutrition (high protein content in high group if available), protein supplements, and parenteral nutrition or amino acids only (as clinically available). The only difference between the 2 groups is the protein targets that are set. Similar efforts should be used in both groups to achieve at least 80% of these targets. The remainder of care provided to eligible patients will be at the discretion of ICU providers.
The investigator has posed two research questions:
Primary Research Question:
In critically ill patients with nutrition 'risk factors', what is the effect of prescribing a higher dose (≥2.2 grams/kg/day) of protein/amino acid administration compared to a usual dose prescribed ≤1.2 gram/kg/day on time to discharge alive from hospital?
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
- •≥18 years old
- •Nutritionally 'high-risk' (meeting one of the below criteria)
- •Low (≤25) or High BMI (≥35)
- •Moderate to severe malnutrition (as defined by local assessments). We will document the means by which sites are making this determination and capture the elements of the assessment (history of weight loss, history of reduced oral intake, etc.).
- •Frailty (Clinical Frailty Scale 5 or more from proxy)
- •Sarcopenia- (SARC-F score of 4 or more from proxy)
- •From point of screening, projected duration of mechanical ventilation >4 days
- •Requiring mechanical ventilation with actual or expected total duration of mechanical ventilation >48 hours
排除标准
- •>96 continuous hours of mechanical ventilation before screening
- •Expected death or withdrawal of life-sustaining treatments within 7 days from screening
- •The responsible clinician feels that the patient either needs low or high protein
- •Patient requires parenteral nutrition only and site does not have products to reach the high protein dose group.
结局指标
主要结局
Time to discharge alive from hospital
时间窗: 60 day
This is a composite of mortality and length of stay, evaluated up to 60 days post randomization
次要结局
- 60-day mortality(60 day)
研究者
Daren K. Heyland
Director
Clinical Evaluation Research Unit at Kingston General Hospital