PRotein Optimization With eXercise to Improve MUscle Mass and Functional outcomeS - a Pilot Feasibility, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Tolerability of protein intervention (serum creatinine change)
研究概览
简要总结
The investigators have designed a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) to determine the feasibility and safety of a larger multi center, randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children. The investigators aim to determine the impact of the intervention on preservation of muscle mass; and functional status at 1 month and 6 months after randomization.
详细描述
Mortality in U.S. pediatric intensive care units (PICUs) is improving, resulting in an increased focus on the quality of life of survivors who often have persistent physical, cognitive, and psychological impairments. Mechanically ventilated children in particular experience immobilization and poor nutrient intake, which results in muscle loss during acute illness. Early mobility and optimal nutrition during acute critical illness have been associated with muscle mass preservation and decreased duration of mechanical ventilation. These interventions may have the potential to decrease preventable PICU-acquired morbidities. However, the optimal doses and long-term benefits of these interventions have not been shown in randomized studies of critically ill PICU patients.
Thus, the investigators will test the first pediatric-specific, inter-professional intervention that integrates high protein and individualized exercise. This intervention was developed by a team of experts in the fields of nutrition, early mobility, rehabilitative exercise, muscle ultrasound (US), and functional outcomes.
The investigators propose a 2-center, pilot feasibility, randomized controlled trial (PROXIMUS) with the following Specific Aims:
- To determine the feasibility and safety of a randomized open-label trial comparing high protein combined with individualized exercise vs. standard management during the acute phase of critical illness in children;
- To determine the impact of high protein and individualized exercise on preservation of muscle mass; and
- To determine the impact of high protein and individualized exercise on functional status at 1 month and 6 months after randomization.
Outcomes: The investigators will assess feasibility with a composite measure that combines predetermined thresholds for screening, enrollment, allocation, and compliance/adherence with significant separation in doses of protein and exercise between the two arms. Safety will be defined as absence of difference in rates of new renal injury and exercise related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients aged 1 year (corrected) to <18 years
- •Require mechanical ventilation (endotracheal intubation or tracheostomy, or initiation of noninvasive ventilation) in the first 72 hours of PICU admission.
- •Able to consent to participate within 72 hours of initiation of mechanical ventilation initiation.
排除标准
- •Patients unable to receive EN, PN, or who are on a specialized diet incompatible with the study intervention
- •Fulminant liver failure
- •Kidney failure (≥KDIGO Stage 3) without replacement therapy
- •Functional Status Scale score at PICU admission <9
- •End of life/redirection of care
- •ECMO therapy
- •Continuous neuromuscular blockade and/or bedrest is medically or surgically necessitated Participation in a conflicting interventional trial
- •High risk of refeeding syndrome
- •Inborn errors of metabolism
- •High BSA burns.
研究组 & 干预措施
Standard protein and exercise
All enrolled patients randomized to this arm will receive a baseline nutrition and nurse-driven mobility pathway and other evidence-based bundled strategies as standard of care.
干预措施: Protein dosage and rehabilitation team delivered exercise prescription (Other)
High protein plus exercise
High protein nutrition: To achieve the prescribed age-appropriate high protein target, dietitians will use EN preferentially, or if EN is contraindicated, PN may be used. High-protein EN formulas and/or protein supplements (powder or liquid) will be added to formula/breast milk feedings or administered separately in divided bolus doses. Dietitians routinely employ and customize these solutions in their scope of practice. When EN is insufficient to meet protein targets, PN may be prescribed to make up the deficit on or after the end of PICU day 3. Energy and protein delivery adequacy (% of prescribed goal) will be monitored daily by the study team.
Patients in this arm will also be prescribed the age-appropriate highest-level of mobility by the rehabilitation team with a goal of 30 minutes duration, twice daily.
干预措施: Protein dosage and rehabilitation team delivered exercise prescription (Other)
结局指标
主要结局
Tolerability of protein intervention (serum creatinine change)
时间窗: Through study completion, up to 10 days
Incidence of treatment-related adverse events as assessed by 3-fold rise in serum creatinine or intolerance (new emesis or diarrhea) related to the study diet.
Safety of protein (new renal injury) and exercise interventions (any associated adverse events)
时间窗: Through study completion, up to 10 days
Incidence of treatment-related adverse events; specifically new renal injury or injury/discomfort associated with exercise.
Feasibility of recruitment and adherence to study procedures
时间窗: Through study completion, up to 10 days
Feasibility (primary composite outcome) will be assessed by the following metrics: (1) \>80% of eligible patients are approached for consent; (2) \>35% of eligible patients are randomized (enrollment and consent); (3) \>80% of consented patients receive study treatments (allocation and adherence).
次要结局
- Multidimensional Pediatric Health related Quality of Life assessment (Physical, Emotional, Social, School Functioning domains) using a validated tool(6 months)
- Change in Muscle mass thickness(Through study completion, up to 10 days)
- Functional assessment - motor, cognitive and responsibility(6 months)
- Assessment of Functional status - sensory, communication, motor, sensory and feeding(6 months)
研究者
Nilesh M. Mehta
Faculty, Critical Care; Professor of Anesthesia
Boston Children's Hospital