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

Primary Purpose

Critical Illness, ICU Acquired Weakness, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Optimisation of nutrition therapy coupled with early mobilisation
Standard care
Sponsored by
HEIDEGGER CP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Early nutrition therapy, Early mobilisation, Long stay ICU patient, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service of Intensive Care, Geneva University Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Walking distance
6 MWT

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2023
Last Updated
May 9, 2023
Sponsor
HEIDEGGER CP
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1. Study Identification

Unique Protocol Identification Number
NCT05865314
Brief Title
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)
Acronym
NutriPhyT
Official Title
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
HEIDEGGER CP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, ICU Acquired Weakness, Malnutrition
Keywords
Early nutrition therapy, Early mobilisation, Long stay ICU patient, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Optimisation of nutrition therapy coupled with early mobilisation
Intervention Description
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
Intervention Name(s)
Standard care
Intervention Description
Patients will receive nutritional therapy and mobilisation according to local standard procedures.
Primary Outcome Measure Information:
Title
Walking distance
Description
6 MWT
Time Frame
Hospital discharge or end of the intervention (4 weeks after ICU discharge)
Secondary Outcome Measure Information:
Title
Walking distance
Description
6 MWT
Time Frame
At ICU discharge (if achievable); 6 months post-ICU stay
Title
Body composition
Description
Electrical bio impedance
Time Frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Body composition
Description
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
Title
Grip Strength
Description
Handgrip
Time Frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Gradation of muscle function
Description
MRC
Time Frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Physical functionality
Description
PFIT & SPPB
Time Frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Weight difference
Description
Comparison between weight at ICU admission, at hospital discharge and at 6 months post-ICU stay
Time Frame
At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Appetite
Description
10-point survey scale
Time Frame
At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Title
Food intake estimation
Description
3 days food diary
Time Frame
At 6 months post-ICU stay
Title
Quality of life (SF-12)
Description
SF-12
Time Frame
At 6 months post-ICU stay
Title
Return to work/activity preceding to the event
Description
Collected during the 6 month post-ICU stay consultation
Time Frame
At 6 months post-ICU stay
Title
Length of ICU and hospital stay
Description
Collected in the patient form
Time Frame
At ICU and hospital discharge
Title
Duration of mechanical ventilation
Description
Collected in the patient form
Time Frame
At ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Heidegger, MD
Phone
+ 41 22 37 27 440
Email
claudia.heidegger@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Aude de Watteville, Bsc
Phone
+ 41 79 55 33 998
Email
aude.dewatteville@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Heidegger, MD
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service of Intensive Care, Geneva University Hospital,
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Heidegger, MD
Email
claudia.heidegger@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Aude De Watteville, Bsc
Email
aude.dewatteville@hcuge.ch

12. IPD Sharing Statement

Learn more about this trial

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

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