Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients

Sarcopenia Clinical Trial

— PROTECT  

Official title:

The Copenhagen PROTECT Study: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151108
• Other study ID #: H-19039214
• Status: Completed
• Start date: November 4, 2019
• Est. completion date: February 1, 2022

Study information

• Verified date: August 2022
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

As humans age, there is a gradual loss of skeletal muscle mass and strength, termed sarcopenia. The underlying causes of sarcopenia are yet not fully elucidated but are thought to be multifactorial and include increased levels of systemic pro-inflammatory mediators, a decrease in anabolic hormones and changes in the neuromuscular system. Furthermore, physical inactivity, chronic diseases, immobilisation and hospitalisation are known to play an important part in the development of sarcopenia.

The prevalence of sarcopenia ranges from 20-30% (aged >70yrs) within the general community. However, the prevalence of sarcopenia in geriatric patients after an acute hospital admission is substantially higher, estimated at ≈50%. Furthermore, successive events of hospitalisation have been suggested to contribute to the development of sarcopenia, as even short periods (4-5 days) of skeletal muscle disuse are known to induce muscle atrophy.

Mean length of hospital stay in geriatric wards due to acute illness or hip-fracture is typically 7 to 11 days during which the level of physical activity is strongly reduced leading to an accelerated loss of muscle mass that many older patients never recover from.

Notably, a substantial part of the deterioration in functional capacity could be avoided just by counteracting loss of muscle mass during hospitalization. As such, we need to identify sensitive biological, clinical and functional biomarkers predicting loss of muscle mass and function during hospitalization to identify patients at risk of developing sarcopenia. Additionally, it is crucial to investigate the association of these biomarkers with hospital length of stay, as hospitalisation has been suggested to contribute to the development of sarcopenia while longer hospital stays may increase patient risk of hospital-acquired infections and place an economic burden on society.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: February 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• equal to or over the age of 65

• admitted to the acute ward at Bispebjerg Hospital

Exclusion Criteria:

• age under 65 years

• terminal illness

• participants who do not understand Danish

• participants in isolation with airborne or droplet infections

Related Conditions & MeSH terms

• Length of Stay
• Muscle Loss
• Sarcopenia

Intervention

Other:
• Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers
Blood tests, frailty (CSHA Clinical Frailty Scale) and risk of pressure ulcers (Braden Score), Early Warning Score (EWS), sarcopenia (SARC-F), malnutrition (SNAQ), cognitive status, comorbidity (Charlson comorbidity Index), polypharmacy, muscle strength, and body composition (BIA)
• Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers
Blood tests, frailty (CSHA Clinical Frailty Scale), Early Warning Score (EWS), cognitive status, sarcopenia (SARC-f), malnutrition (SNAQ), comorbidity (Charlson comorbidity Index), polypharmacy, physical function, physical performance, and body composition (BIA)

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Hours of admission from index to discharge	From date of hospital admission until discharge, assessed up to 2 months
Primary	Change in muscle mass	Relative change in muscle mass during hospitalization	Change from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days
Primary	Change in muscle strength	Change in handgrip strength during hospitalization	Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days
Primary	Change in physical function	Change in chair-rise and gait-speed ability during hospitalization	Change from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 days
Secondary	Readmission	Time to readmission from discharge	Time to readmission 90 days from discharge
Secondary	Mortality	Time to mortality from index admission	Time to mortality 90 days from index admission