Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)

Conditions
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Critical Illness, ICU Acquired Weakness, Malnutrition

Intervention / Treatment
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* Other: Optimisation of nutrition therapy coupled with early mobilisation
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br> | Other: Optimisation of nutrition therapy coupled with early mobilisation<br>* Optimisation of nutrition therapy coupled with early mobilisation with: Optimisation of nutrition therapy during ICU stay Optimisation of physiotherapy during ICU stay Better communication and closer collaboration between physiotherapy and nutrition teams. Optimisation of continuity of the care.<br>|
| Active Comparator: Control group<br> | Other: Standard care<br>* Patients will receive nutritional therapy and mobilisation according to local standard procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | 6 MWT | Hospital discharge or end of the intervention (4 weeks after ICU discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | 6 MWT | At ICU discharge (if achievable); 6 months post-ICU stay | 
| Body composition | Electrical bio impedance | At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Body composition | Peripheral muscle ultrasound | 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 | Handgrip | At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Gradation of muscle function | MRC | At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Physical functionality | PFIT & SPPB | At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Weight difference | Comparison between weight at ICU admission, at hospital discharge and at 6 months post-ICU stay | At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Appetite | 10-point survey scale | At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay | 
| Food intake estimation | 3 days food diary | At 6 months post-ICU stay | 
| Quality of life (SF-12) | SF-12 | At 6 months post-ICU stay | 
| Return to work/activity preceding to the event | Collected during the 6 month post-ICU stay consultation | At 6 months post-ICU stay | 
| Length of ICU and hospital stay | Collected in the patient form | At ICU and hospital discharge | 
| Duration of mechanical ventilation | Collected in the patient form | At ICU discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early nutrition therapy, Early mobilisation, Long stay ICU patient, Physiotherapy