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

HEIDEGGER CP

Status: Enrolling

Conditions: Malnutrition; Critical Illness; ICU Acquired Weakness

Treatments: Other: Standard care; Other: Optimisation of nutrition therapy coupled with early mobilisation

Study type: Interventional

Funder types: Other

Identifiers

NCT05865314

NutriPhyT2022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Interventional group

Experimental group

Treatment:

Other: Optimisation of nutrition therapy coupled with early mobilisation

Control group

Active Comparator group

Treatment:

Other: Standard care