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

NCT ID: NCT05865314

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-09-01

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.

Conditions

Critical Illness; ICU Acquired Weakness; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional group

Group Type: EXPERIMENTAL

Optimisation of nutrition therapy coupled with early mobilisation

Intervention Type: OTHER

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.

Control group

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

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

Interventions

Optimisation of nutrition therapy coupled with early mobilisation

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.

Intervention Type: OTHER

Standard care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HEIDEGGER CP

OTHER

Sponsor Role: lead

Responsible Party

HEIDEGGER CP

Deputy head physician, Head of the Intensive Care Polyvalent Unit, Division of Intensive Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia Heidegger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Service of Intensive Care, Geneva University Hospital,

Geneva, Canton of Geneva, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Claudia Heidegger, MD

Role: CONTACT

claudia.heidegger@hcuge.ch

+ 41 22 37 27 440

Aude de Watteville, Bsc

Role: CONTACT

aude.dewatteville@hcuge.ch

+ 41 79 55 33 998

Facility Contacts

Claudia Heidegger, MD

Role: primary

claudia.heidegger@hcuge.ch

Aude De Watteville, Bsc

Role: backup

aude.dewatteville@hcuge.ch

Other Identifiers

NutriPhyT2022

Identifier Type: -

Identifier Source: org_study_id