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

Critical Illness Clinical Trial

Official title:

Ultrasound Assessment of Muscle to Quantify Frailty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270502
• Other study ID #: 2014P000249
• Status: Completed
• Phase: N/A
• First received: October 17, 2014
• Last updated: March 16, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Critical Illness
• Muscle Wasting
• Muscular Atrophy
• Sarcopenia

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical intensive care unit length of stay	Time from study inclusion to SICU discharge, an expected time of 2 days to 2 weeks.	Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Secondary	Hospital length of stay	Time from study inclusion to hospital discharge, an expected time of 4 days to 4 weeks	Patients will be followed until hospital discharge, an expected 4 days to 4 weeks
Secondary	Discharge Disposition	Discharge disposition of the patient expressed as home, rehabilitation, nursing facility or in-hospital mortality.	Patient will be followed until hospital discharge, an expected 4 days to 4 weeks
Secondary	Ventilator-free days	Days spent on the SICU that patient is not receiving mechanical ventilation	Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.