Clinical trial NCT05865314: Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)
Official title: Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
ICU Acquired Weakness
Malnutrition
Keywords: Early nutrition therapy
Early mobilisation
Long stay ICU patient
Physiotherapy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking distance
timeFrame: Hospital discharge or end of the intervention (4 weeks after ICU discharge)
Secondary outcomes:
measure: Walking distance
timeFrame: At ICU discharge (if achievable); 6 months post-ICU stay
measure: Body composition
timeFrame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Body composition
timeFrame: 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
measure: Grip Strength
timeFrame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Gradation of muscle function
timeFrame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Physical functionality
timeFrame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Weight difference
timeFrame: At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Appetite
timeFrame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
measure: Food intake estimation
timeFrame: At 6 months post-ICU stay
measure: Quality of life (SF-12)
timeFrame: At 6 months post-ICU stay
measure: Return to work/activity preceding to the event
timeFrame: At 6 months post-ICU stay
measure: Length of ICU and hospital stay
timeFrame: At ICU and hospital discharge
measure: Duration of mechanical ventilation
timeFrame: At ICU discharge
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Service of Intensive Care, Geneva University Hospital,
Study officials:
affiliation: University Hospital, Geneva
name: Claudia Heidegger, MD
role: PRINCIPAL_INVESTIGATOR
References: