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

ConditionsCritical IllnessICU Acquired WeaknessMalnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHEIDEGGER CP

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old

On mechanical ventilation with an expected length of stay ≥ 7 days

Requiring artificial nutrition (enteral and/or parenteral nutrition)

Disqualifiers

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

Transfer to another ICU

Patient living abroad from Switzerland

Trial design

Design model

Parallel

Treatments tested in this trial

  • Optimisation of nutrition therapy coupled with early mobilisation

    Other intervention

    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.

  • Standard care

    Other intervention

    Patients will receive nutritional therapy and mobilisation according to local standard procedures.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Interventional groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Walking distance

6 MWT

Time frame
Hospital discharge or end of the intervention (4 weeks after ICU discharge)

Secondary outcomes

1

Walking distance

6 MWT

Time frame
At ICU discharge (if achievable); 6 months post-ICU stay
2

Body composition

Electrical bio impedance

Time frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
3

Body composition

Peripheral muscle ultrasound

Time frame
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
4

Grip Strength

Handgrip

Time frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HEIDEGGER CP

Lead sponsor

University Hospital, Geneva

Sponsor institution

Source ClinicalTrials.gov
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