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

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ClinicalTrials.gov Identifier: NCT04151108
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Charlotte Suetta, Bispebjerg Hospital

Brief 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.


Condition or disease Intervention/treatment
Sarcopenia Muscle Loss Length of Stay Other: Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers Other: Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The Copenhagen PROTECT Study: Biomarkers for Length of Hospital Stay and Loss of Muscle Mass and Function in Old Medical Patients
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Old medical patients

Blood tests, frailty (CSHA Frailty Scale), risk of pressure ulcers (Braden Score), handgrip strength, Orientation-Memory-Concentration test (OMC), screening for sarcopenia (SARC-F), body composition.

Will be assessed at admission

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, cognitive status, comorbidity (Charlson comorbidity Index), polypharmacy, handgrip strength and body composition (BIA)

Geriatric patients

Blood tests, frailty (CSHA Frailty Scale), risk of pressure ulcers (Braden Score), handgrip strength, chair-rise test, gait-speed, Orientation-Memory-Concentration test (OMC), screening for sarcopenia (SARC-F), body composition.

Blood tests, physical function measures and body composition will be assessed at both admission and discharge.

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, cognitive status, comorbidity (Charlson comorbidity Index), polypharmacy, handgrip strength and body composition (BIA)

Other: 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, comorbidity (Charlson comorbidity Index), polypharmacy, physical function and body composition (BIA)




Primary Outcome Measures :
  1. Length of stay [ Time Frame: From date of hospital admission until discharge, assessed up to 2 months ]
    Hours of admission from index to discharge

  2. Change in muscle mass [ Time Frame: Change from baseline muscle mass, assessed at admission, to muscle mass assessed at discharge, an average of 10 days ]
    Relative change in muscle mass during hospitalization

  3. Change in muscle strength [ Time Frame: Change from baseline muscle strength, assessed at admission, to muscle strength assessed at discharge, an average of 10 days ]
    Change in handgrip strength during hospitalization

  4. Change in physical function [ Time Frame: Change from baseline physical function, assessed at admission, to physical function assessed at discharge, an average of 10 days ]
    Change in chair-rise and gait-speed ability during hospitalization


Secondary Outcome Measures :
  1. Readmission [ Time Frame: Time to readmission 90 days from discharge ]
    Time to readmission from discharge

  2. Mortality [ Time Frame: Time to mortality 90 days from index admission ]
    Time to mortality from index admission


Biospecimen Retention:   Samples Without DNA
Plasma and serum


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of participants admitted to the acute ward and the geriatric ward at Bispebjerg Hospital
Criteria

Inclusion Criteria:

  • equal to or over the age of 65
  • admitted to the acute ward at Bispebjerg Hospital

Exclusion Criteria:

  • age under 65 years
  • admission lasting less than 24 hours
  • terminal illness
  • participants who do not understand Danish
  • participants in isolation with airborne or droplet infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151108


Contacts
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Contact: Rikke S Kamper, MSc. +4531510308 rikke.stefan.kamper.01@regionh.dk
Contact: Charlotte A Suetta, Professor +4523339493 charlotte.suetta@regionh.dk

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Rikke S Kamper, MSc.    +4531510308    rikke.stefan.kamper.01@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Charlotte A Suetta, Professor Geriatric Research Unit, Bispebjerg Hospital

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Responsible Party: Charlotte Suetta, Professor, MD, Dr.Med., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04151108     History of Changes
Other Study ID Numbers: H-19039214
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The following will be available: Study Protocol and Statistical Analysis Plan (SAP).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms