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Effects of Frailty, Sarcopenia and Muscle Wasting on Outcomes of Patients in the Surgical Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT02270502
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief Summary:

The primary aim of the study is to evaluate consequences of frailty in critically ill patients. We hypothesize that a higher frailty index (based on published questionnaires) predicts a longer surgical intensive care unit and hospital length of stay, less ventilator-free days and a higher likelihood of an adverse discharge disposition.

Our secondary aim is to identify muscle-size derived variables that can be used to predict frailty. We hypothesize that a low skeletal muscle mass measured by ultrasound can be used to quantify frailty, and to also predict the outcome of SICU patients, expressed as longer stay in the surgical intensive care unit and longer stay in the hospital, less ventilator-free days and a higher likelihood of an adverse discharge disposition.

Our third aim is to examine potential triggers of muscle wasting in critically ill patients. Muscle wasting will be assessed by repetitive ultrasound measurements of muscle mass. We hypothesize that a significant decrease in skeletal muscle mass predicts longer stay at the surgical intensive care unit and longer hospital length of stay, less ventilator-free days and adverse discharge disposition.


Condition or disease Intervention/treatment
Critical Illness Sarcopenia Muscle Wasting Device: Ultrasound Philips CX50 Other: Frailty Index Questionnaire Other: Muscle strength tests

Detailed Description:

Frailty is defined as status of decreased physiological reserve which leads to a higher vulnerability to stressors. It is associated with a higher risk of morbidity and mortality. Within the geriatric population, frailty is common and a known predictor of adverse outcomes. The usefulness of a frailty assessment as an outcome measure in critically ill patients of all ages needs to be evaluated. This study evaluates whether frailty has an effect on outcome of critically ill patients.

Muscle weakness predicts outcome of ICU patients but is hard to determine in the ICU since the measurement is volition dependent. Muscle mass correlates with muscle weakness and can be assessed objectively. This study evaluates the consequences of reduced muscle mass or sarcopenia on the outcome of critically ill patients.

In addition, muscle wasting in the ICU may predict persistent functional disability. This study aims to examine muscle wasting of critically ill patients on the surgical ICU.

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Assessment of Muscle to Quantify Frailty.
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
Adult patients on the SICU
Adult patients on the surgical intensive care unit (SICU), within 72 hours of admission to the SICU and until SICU discharge. Ultrasound Philips CX50, Frailty Index questionnaire and muscle strength tests.
Device: Ultrasound Philips CX50
The Philips CX50 ultrasound system is used to measure muscle size of the patients. We will measure the area and diameter of the rectus femoris muscle via ultrasound.

Other: Frailty Index Questionnaire
Frailty Index Questionnaire is a clinical tool to assess frailty in patients. We will ask patients to answer the questionnaire, including clarification that the questionnaire assesses the patient's pre-admission condition. The presence of a frail characteristic will be scored as 1 point. Most variables will be dichotomized (e.g. 1 point when a frail characteristic will be present and 0 points when frail characteristic will be not present).The Frailty Index will be calculated as the total number of frail characteristics of the patient divided by the total number of variables (n=50).

Other: Muscle strength tests
MRC score is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement.




Primary Outcome Measures :
  1. Surgical intensive care unit length of stay [ Time Frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks. ]
    Time from study inclusion to SICU discharge, an expected time of 2 days to 2 weeks.


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Patients will be followed until hospital discharge, an expected 4 days to 4 weeks ]
    Time from study inclusion to hospital discharge, an expected time of 4 days to 4 weeks

  2. Discharge Disposition [ Time Frame: Patient will be followed until hospital discharge, an expected 4 days to 4 weeks ]
    Discharge disposition of the patient expressed as home, rehabilitation, nursing facility or in-hospital mortality.

  3. Ventilator-free days [ Time Frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks. ]
    Days spent on the SICU that patient is not receiving mechanical ventilation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the surgical intensive care unit (SICU)
Criteria

Inclusion Criteria:

  • Patients admitted to the SICU (within 72 hours of admission)
  • Age over 18 years
  • Stay on the SICU for at least 24 hours

Exclusion Criteria:

  • Ongoing discussions about goals of care
  • Motor component of Glasgow Coma Scale <5
  • Unstable fractures
  • Preexisting paralysis
  • Pregnancy
  • Absence of both lower limbs

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): NCT02270502


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Matthias Eikermann, MD, PhD Massachussetts General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthias Eikermann, Director of Research, Critical Care Division, Associate Professor of Anesthesia, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02270502    
Other Study ID Numbers: 2014P000249
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
critically illness
intensive care unit
outcome
frailty
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Wasting Syndrome
Frailty
Critical Illness
Cachexia
Pathologic Processes
Disease Attributes
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders