Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Walking distance
研究概览
简要总结
Due to medical advances and quality of care, mortality in adult intensive care units (ICUs) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the ICU.
A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days).
This study aim to assess whether an optimization of the nutritional therapy coupled with an early mobility during and after the ICU stay allows an improvement in the muscle function at hospital discharge compared to patients receiving the standard care.
详细描述
Due to medical advances and quality of care, mortality in adult intensive care units (ICUs) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the ICU. Indeed, these patients are at high risk of complications related to their ICU stay (cognitive impairment, ICU acquired weakness, diaphragm dysfunction, ICU polyneuropathy, post-traumatic stress, malnutrition, etc.). Despite prolonged periods of rehabilitation, there is a significant decrease in functional status and quality of life compared to the previous status of these patient.
A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days) including special attention to weaning from ventilation, nutrition, mobilisation, anxiety, pain, skin condition etc.
The culture of nutritional therapy and early mobilisation is already well established at the Geneva-ICU. However, a comprehensive approach to nutrition and mobilisation during and after the ICU stay could be optimised.
The objective of the study is to determine whether optimization of nutritional therapy combined with early mobilization for patients with long ICU stay will improve muscle function at discharge compared with patients receiving standard care.
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
- 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
- •Any patient admitted to the adult ICU :
- •≥18 years old
- •On mechanical ventilation with an expected length of stay ≥ 7 days
- •Requiring artificial nutrition (enteral and/or parenteral nutrition)
排除标准
- •Therapeutic withdrawal Pregnant or breastfeeding patients
- •Neurological disorders with motor deficits:
- •New or pre-existing neuromuscular or nervous system disease
- •Spinal cord injury Severe polytrauma of the lower limbs (amputation etc.) Non-independent ambulation (including walking aids) before ICU admission
- •For organizational reasons not allowing follow-up :
- •Transfer to another ICU
- •Patient living abroad from Switzerland
- •Patient living in nursing homes preceding to ICU admission
- •Incarcerated patients
- •Intellectual/cognitive disabilities or language barrier, limiting ability to follow the instructions
结局指标
主要结局
Walking distance
时间窗: Hospital discharge or end of the intervention (4 weeks after ICU discharge)
6 MWT
次要结局
- Food intake estimation(At 6 months post-ICU stay)
- Walking distance(At ICU discharge (if achievable); 6 months post-ICU stay)
- Body composition(Within the 1st 48 hours post ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Grip Strength(At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Gradation of muscle function(At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Weight difference(At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Return to work/activity preceding to the event(At 6 months post-ICU stay)
- Physical functionality(At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Appetite(At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay)
- Quality of life (SF-12)(At 6 months post-ICU stay)
- Duration of mechanical ventilation(At ICU discharge)
- Length of ICU and hospital stay(At ICU and hospital discharge)
研究者
HEIDEGGER CP
Deputy head physician, Head of the Intensive Care Polyvalent Unit, Division of Intensive Care
University Hospital, Geneva