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

Not Applicable

Recruiting

• Conditions: Critical Illness; Malnutrition; ICU Acquired Weakness
• Interventions: Other: Optimisation of nutrition therapy coupled with early mobilisation; Other: Standard care

• Registration Number: NCT05865314
• Lead Sponsor: HEIDEGGER CP

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.

Study Timeline

• Study First Submitted: 2023-03-23
• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-18
• Last Update Posted: 2023-05-18
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Optimisation of nutrition therapy coupled with early mobilisation	-
Control group	Standard care	-

Primary Outcome Measures

Name	Time	Method
Walking distance	Hospital discharge or end of the intervention (4 weeks after ICU discharge)	6 MWT

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service of Intensive Care, Geneva University Hospital,; 🇨🇭 Geneva, Switzerland