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

Completed

• Conditions: Muscle Wasting; Critical Illness; Sarcopenia
• Interventions: Device: Ultrasound Philips CX50; Other: Frailty Index Questionnaire; Other: Muscle strength tests

• Registration Number: NCT02270502
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients on the SICU	Ultrasound Philips CX50	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.
Adult patients on the SICU	Frailty Index Questionnaire	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.
Adult patients on the SICU	Muscle strength tests	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.

Primary Outcome Measures

Name	Time	Method
Surgical intensive care unit length of stay	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

Name	Time	Method
Hospital length of stay	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	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	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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States