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
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|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|
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.
- 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.
- 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
- 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.
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Matthias Eikermann, MD, PhD||Massachussetts General Hospital|