Service of Intensive Care, Geneva University Hospital,
Geneva, Canton of Geneva, 1211, Switzerland
Location status: Recruiting
NCT Number: NCT05865314
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Geneva, Canton of Geneva, 1211, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Any patient admitted to the adult ICU :
Exclusion criteria
Therapeutic withdrawal Pregnant or breastfeeding patients
Neurological disorders with motor deficits:
For organizational reasons not allowing follow-up :
Optimisation of nutrition therapy coupled with early mobilisation with:
Patients will receive nutritional therapy and mobilisation according to local standard procedures.
Time frame: Hospital discharge or end of the intervention (4 weeks after ICU discharge)
6 MWT
Time frame: At ICU discharge (if achievable); 6 months post-ICU stay
6 MWT
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Electrical bio impedance
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
Peripheral muscle ultrasound
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Handgrip
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
MRC
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
PFIT & SPPB
Time frame: 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
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
10-point survey scale
Time frame: At 6 months post-ICU stay
3 days food diary
Time frame: At 6 months post-ICU stay
SF-12
Time frame: At 6 months post-ICU stay
Collected during the 6 month post-ICU stay consultation
Time frame: At ICU and hospital discharge
Collected in the patient form
Time frame: At ICU discharge
Collected in the patient form
Contact information is provided by the study sponsor or research team.
Aude de Watteville, Bsc
CONTACT
Claudia Heidegger, MD
CONTACT
HEIDEGGER CP
Other
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)
Acronym: NutriPhyT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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