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

NCT02270502 | Completed

• 1 other identifier: 2014P000249
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Sarcopenia; Muscle Wasting

Keywords

critically illness; intensive care unit; outcome; frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospital length of stay

  Patients will be followed until hospital discharge, an expected 4 days to 4 weeks

• Discharge Disposition

  Patient will be followed until hospital discharge, an expected 4 days to 4 weeks

• Ventilator-free days

  Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.

Study Arms (1)

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; Other: Frailty Index Questionnaire; Other: Muscle strength tests

Interventions

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.

Adult patients on the SICU

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).

Adult patients on the SICU

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.

Adult patients on the SICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in the surgical intensive care unit (SICU)

You may qualify if:

• Patients admitted to the SICU (within 72 hours of admission)
• Age over 18 years
• Stay on the SICU for at least 24 hours

You may not qualify if:

• Ongoing discussions about goals of care
• Motor component of Glasgow Coma Scale \<5
• Unstable fractures
• Preexisting paralysis
• Pregnancy
• Absence of both lower limbs

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 26655919 DERIVED

MeSH Terms

Conditions

Critical Illness; Sarcopenia; Muscular Atrophy; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Matthias Eikermann, MD, PhD

  Massachussetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Critical Care Division, Associate Professor of Anesthesia, Harvard Medical School

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)