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

Critical Illness Clinical Trial

— NutriPhyT  

Official title:

Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865314
• Other study ID #: NutriPhyT2022
• Status: Recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: Claudia Heidegger, MD
• Phone: + 41 22 37 27 440
• Email: claudia.heidegger[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• ICU Acquired Weakness
• Malnutrition

Intervention

Other:
• 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.
• Standard care
Patients will receive nutritional therapy and mobilisation according to local standard procedures.

Locations

Country	Name	City	State
Switzerland	Service of Intensive Care, Geneva University Hospital,	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
HEIDEGGER CP

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking distance	6 MWT	Hospital discharge or end of the intervention (4 weeks after ICU discharge)
Secondary	Walking distance	6 MWT	At ICU discharge (if achievable); 6 months post-ICU stay
Secondary	Body composition	Electrical bio impedance	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Body composition	Peripheral muscle ultrasound	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
Secondary	Grip Strength	Handgrip	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Gradation of muscle function	MRC	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Physical functionality	PFIT & SPPB	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Weight difference	Comparison between weight at ICU admission, at hospital discharge and at 6 months post-ICU stay	At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Appetite	10-point survey scale	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Secondary	Food intake estimation	3 days food diary	At 6 months post-ICU stay
Secondary	Quality of life (SF-12)	SF-12	At 6 months post-ICU stay
Secondary	Return to work/activity preceding to the event	Collected during the 6 month post-ICU stay consultation	At 6 months post-ICU stay
Secondary	Length of ICU and hospital stay	Collected in the patient form	At ICU and hospital discharge
Secondary	Duration of mechanical ventilation	Collected in the patient form	At ICU discharge