Clinical trial NCT02270502: Effects of Frailty, Sarcopenia and Muscle Wasting on Outcomes of Patients in the Surgical Intensive Care Unit
Official title: Ultrasound Assessment of Muscle to Quantify Frailty.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Sarcopenia
Muscle Wasting
Keywords: critically illness
intensive care unit
outcome
frailty
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the surgical intensive care unit (SICU)

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.

Eligibility 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

Primary outcomes:
measure: Surgical intensive care unit length of stay
timeFrame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Patients will be followed until hospital discharge, an expected 4 days to 4 weeks
measure: Discharge Disposition
timeFrame: Patient will be followed until hospital discharge, an expected 4 days to 4 weeks
measure: Ventilator-free days
timeFrame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachussetts General Hospital
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller N, Murthy S, Tainter CR, Lee J, Riddell K, Fintelmann FJ, Grabitz SD, Timm FP, Levi B, Kurth T, Eikermann M. Can Sarcopenia Quantified by Ultrasound of the Rectus Femoris Muscle Predict Adverse Outcome of Surgical Intensive Care Unit Patients as well as Frailty? A Prospective, Observational Cohort Study. Ann Surg. 2016 Dec;264(6):1116-1124. doi: 10.1097/SLA.0000000000001546.