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NCT Number: NCT03917667

Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EWGSOP2

Diagnostic Test

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Murielle Surquin

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 17, 2019
Registry last updated
Jun 10, 2022

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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