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Completed

NCT Number: NCT02270502

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

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.

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Key information

Conditions

Critical Illness Atrophy Disease Attributes Frailty Muscle Wasting Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasound Philips CX50

Device

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.

Frailty Index Questionnaire

Other

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).

Muscle strength tests

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Ultrasound Assessment of Muscle to Quantify Frailty.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2014
Registry last updated
Mar 17, 2016

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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