The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-based Randomized Trial - The EFFORT Trial and EFFORT Outcomes Sub-study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- 6-minute walk test (6MWT)
研究概览
简要总结
The investigators will evaluate the effects of higher protein/amino acid dosing (≥2.2 g/kg/d) vs usual care of protein/amino acid dosing (≤1.2 g/kg/d) over muscle mass in nutritionally high risk ill patients
详细描述
The EFFORT Outcomes is a sub-study of the parent EFFORT trial; a multi-center, pragmatic, volunteer-driven, registry-based, randomized, clinical trial of 4000 nutritionally high-risk critically ill patients in the intensive care unit. Patients will be randomized to 1 of 2 treatment groups: a usual care 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.
In patients included in the OUTCOMES sub-study, we will test the patient's functional recovery and long-term quality of life. Patients will undergo the US measures at baseline (within 24 hours of randomization, 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done. To ensure standardization and quality in the measures, we have created high quality training materials and will have US films sent centrally to abstract all measurements. In the first 10 patients enrolled in the US sub-study, participating sites will conduct a run-in phase where their submitted data will be evaluated for quality and reliability (both intra and inter-rater reliability) to ensure subsequent measures are of high quality. Nutritional and clinical data for these patients will be included in the parent EFFORT trial but the US measures may be omitted if quality is poor.
The investigator has posed the following research question:
Primary Outcome of the OUTCOMES Sub-study
The primary outcome will be the walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge. Implementation of the test will be based upon the 2014 ATS standards, with adaptation, as needed, for the in-patient setting and ICU survivor population. The 6MWT is a reliable, valid, responsive measure of physical function for survivors of acute respiratory failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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.
- •Not ambulating independently prior to illness that leads to ICU admission (use of gait aid permitted)
- •Lower extremity injury or impairments that prevents them from walking prior to hospital discharge (e.g. amputation, knee/hip injury)
- •Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
- •Pre-existing primary severe systemic neuromuscular disease resulting in severe weakness pre-ICU (e.g., Guillain Barre) 10 Intracranial or spinal process affecting motor function
- •Patients in hospital >5 days prior to ICU admission
- •Not expected to stay ≥4 days after enrollment
结局指标
主要结局
6-minute walk test (6MWT)
时间窗: Within 72 hours before discharge from the hospital
walking distance achieved during a 6-minute walk test (6MWT) measured at hospital discharge
次要结局
- Quadriceps force(Within 72 hours before discharge from the hospital)
- Short Physical Performance Battery (SPPB)(Within 72 hours before discharge from the ICU and hospital)
- Quadriceps Muscle Mass(Day 1 and Day 10 of randomization, and within 72 hours before discharge from the hospital)
- Functional Status Score for ICU (FSS-ICU)(Day 1 of randomization (surrogate interview), within 72 hours before discharge from the ICU and hospital (by trained physiotherapist))
- Handgrip strength(Within 72 hours before discharge from the ICU and hospital)
- Overall strength(Within 72 hours before discharge from the hospital)
研究者
Daren K. Heyland
Director
Clinical Evaluation Research Unit at Kingston General Hospital