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Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+

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ClinicalTrials.gov Identifier: NCT03917667
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Murielle Surquin, Brugmann University Hospital

Brief Summary:

Sarcopenia is a disease characterized by progressive and generalized loss of skeletal muscle mass and strength, and is related to worse clinical outcomes, physical impairment, and mortality in all healthcare settings. This nutrition-related syndrome is a reversible condition, and can be effectively counteracted by exercise and nutritional support.

The prevalence of sarcopenia varies widely depending on the criteria, methods, and cut-off points used for its assessment. Although the European Working Group on Sarcopenia in Older People (EWGSOP) recommended assessing sarcopenia in geriatric patients in all care settings, few studies addressing hospitalized older patients have been carried out, mainly due to the characteristics of acute healthcare settings and their in-patients and because the criteria used are difficult to carry out there. Therefore, this condition remains under-recognized in the setting where this disease is likely to be more present.

Sarcopenia is expected to be a major healthcare problem in the upcoming years in Europe so, in response to this claim for Public Health Action, the European Union Geriatric Medicine Society founded the Special Interest Group (SIG) on sarcopenia that has taken the lead of bridging the gaps between clinical and research in sarcopenia field, in line with the Conference on Frailty and Sarcopenia Research Task Force, and the World Health Organization's strategies to promote Optimal Aging. This goal of SIG on sarcopenia by EuGMS is being carried out by promotion of collaboration among International scientific societies and institutions; they have recently launched the Revised European consensus on definition and diagnosis (EWGSOP2), the SARCUS project on ultrasound for sarcopenia assessment in European countries, and the first International Registry of patients with sarcopenia.

This study aims to provide an overview of sarcopenia assessment older patients hospitalized in acute-care geriatric units.

This is a longitudinal, prospective, observational study in consecutive hospitalized patients in the CHU Brugmann Hospital.

This study has 5 objectives :

  1. To determine prevalence of sarcopenia among hospitalized patients in CHU Brugmann.
  2. To determine incidence of sarcopenia during the hospital stay.
  3. To identify risk factors for the development of sarcopenia at the time of admission and during hospitalization.
  4. To assess sarcopenia as a risk factor for clinical adverse outcomes during hospitalization (hospital-acquired infections, falls, delirium, longer length-of-stay, disability, and mortality).
  5. To assess sarcopenia as a risk factor for clinical adverse outcomes post-discharge (institutionalization, hospitalizations, falls, disability, and mortality) at 3- and 12-month follow-up.

Condition or disease Intervention/treatment
Sarcopenia Diagnostic Test: EWGSOP2

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+
Actual Study Start Date : April 2, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Group/Cohort Intervention/treatment
Geriatric patients
Patients aged 70 years and older who are admitted to the acute care geriatric units.
Diagnostic Test: EWGSOP2
EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia, considered as a dichotomous variable -yes/no- in presence of low grip strength + low muscle mass + low gait speed.




Primary Outcome Measures :
  1. Prevalence of sarcopenia at hospital admission [ Time Frame: 72 hours ]
    Prevalence of sarcopenia at hospital admission. A prevalent case of sarcopenia will be considered if a patient fulfills the EWGSOP2 at admission

  2. Incidence of sarcopenia between admission and discharge [ Time Frame: Up to 20 days ]
    A incident case of sarcopenia will be considered if a patient that do not fulfill EWGSOP2 diagnostic criteria at admission, fulfills the diagnostic criteria at discharge (diagnosis will be considered as a dichotomous variable -yes/no-).

  3. Occurence of risk factors [ Time Frame: Up to 20 days ]
    Presence of at least one risk factor involved in the development of sarcopenia during hospitalization. Risk factors defined as: bed immobilization, denutrition, loss of autonomy, cognitive troubles, depression, mobility loss.

  4. Occurence of adverse events [ Time Frame: Up to 20 days ]
    Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.

  5. Occurence of adverse events [ Time Frame: 3 months after hospital discharge ]
    Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.

  6. Occurence of adverse events [ Time Frame: 1 year after hospital discharge ]
    Presence of at least one adverse event of the following list: Falls, Fracture, Delirium, Aspiration, Pneumonia, Urinary tract infection, Gastrointestinal infection, Sepsis, Gastrointestinal bleeding, Decubitus ulcer (Bed sores), Deep vein thrombosis, Pulmonary embolism, Arrythmia, Stroke, Myocardial infarction, Cardiopulmonary arrest, Death, Date of death, Hospital re-admission, Institutionalisation, Emergency Department visits.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 70 years and older who are admitted to the acute care geriatric units of the CHU Brugmann Hospital. This may include acute medical conditions or chronic disease decompensation; patients are eligible for referral to acute geriatric units due to medical diseases, such as urinary tract infections, respiratory tract infections, pneumonia, coronary heart diseases, atrial fibrillation, congestive heart failure, stroke, delirium, electrolyte disturbances, kidney disease, cancer, etc...
Criteria

Inclusion Criteria:

- Patients aged 70 years and older who are admitted to the acute care geriatric units of the CHU Brugmann Hospital.

Exclusion Criteria:

  • Hip or lower limbs fractures, amputations,
  • Terminally ill patients admitted for palliative care,
  • Neurological patients with hemiplegia or stroke limiting the walking evaluation

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): NCT03917667


Contacts
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Contact: Murielle Surquin, MD 32 2 4772223 Murielle.SURQUIN@chu-brugmann.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Murielle Surquin, MD         
Sponsors and Collaborators
Murielle Surquin
Investigators
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Principal Investigator: Murielle Surquin, MD CHU Brugmann

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Responsible Party: Murielle Surquin, Head of Geriatry Department, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03917667     History of Changes
Other Study ID Numbers: CHUB-Sarcopenia 9+
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murielle Surquin, Brugmann University Hospital:
Sarcopenia

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