Critical IllnessNCT02270502
Effects of Frailty, Sarcopenia and Muscle Wasting on Outcomes of Patients in the Surgical Intensive Care Unit
An observational study of Critical Illness and Sarcopenia, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sarcopenia, Muscle Wasting
- What is being tested?
- Ultrasound Philips CX50, Frailty Index Questionnaire and Muscle strength tests
- Type of treatment
- Medical device
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the surgical intensive care unit (SICU)
Who may be able to join
- Patients admitted to the SICU (within 72 hours of admission)
- Age over 18 years
- Stay on the SICU for at least 24 hours
Who cannot join
- Ongoing discussions about goals of care
- Motor component of Glasgow Coma Scale <5
- Unstable fractures
- Preexisting paralysis
- Pregnancy
- Absence of both lower limbs
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Ultrasound Assessment of Muscle to Quantify Frailty.
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.
Read the 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.
- Conditions
- Critical Illness, Sarcopenia, Muscle Wasting
- Being tested
- Ultrasound Philips CX50, Frailty Index Questionnaire, Muscle strength tests
- Keywords
- critically illness, intensive care unit, outcome, frailty
- Medical subject headings
- Critical Illness, Sarcopenia, Muscular Atrophy, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Philips CX50Device
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.
Frailty Index QuestionnaireOther
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 testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultrasound Philips CX50; Other: Frailty Index Questionnaire; Other: Muscle strength tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical intensive care unit length of stay
Time from study inclusion to SICU discharge, an expected time of 2 days to 2 weeks.
Measured: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Secondary outcomes (3)
Hospital length of stay
Time from study inclusion to hospital discharge, an expected time of 4 days to 4 weeks
Measured: Patients will be followed until hospital discharge, an expected 4 days to 4 weeks
Discharge Disposition
Discharge disposition of the patient expressed as home, rehabilitation, nursing facility or in-hospital mortality.
Measured: Patient will be followed until hospital discharge, an expected 4 days to 4 weeks
Ventilator-free days
Days spent on the SICU that patient is not receiving mechanical ventilation
Measured: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias Eikermann, MD, PhD, Principal investigator, Massachussetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270502
- Sponsor's protocol ID
- 2014P000249
- Status last verified
- Mar 2016
- First submitted
- 17 Oct 2014
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26655919
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Muscle to Quantify Frailty.
- ClinicalTrials.gov ID
- NCT02270502
- Acronym / sponsor ID
- 2014P000249
- Conditions
- Critical Illness, Sarcopenia, Muscle Wasting
- Keywords
- critically illness, intensive care unit, outcome, frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients on the SICU | – | Device: Ultrasound Philips CX50, Other: Frailty Index Questionnaire, Other: Muscle strength testsAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the surgical intensive care unit (SICU)
Key inclusion criteria (3 listed)
- Patients admitted to the SICU (within 72 hours of admission)
- Age over 18 years
- Stay on the SICU for at least 24 hours
Key exclusion criteria (6 listed)
- Ongoing discussions about goals of care
- Motor component of Glasgow Coma Scale <5
- Unstable fractures
- Preexisting paralysis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Philips CX50The 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. | Device | Adult patients on the SICU |
| Frailty Index QuestionnaireFrailty 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 | Adult patients on the SICU |
| Muscle strength testsMRC 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. | Other | Adult patients on the SICU |
Primary outcome
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.
3 secondary outcomes
Hospital length of stay
Time frame: Patients will be followed until hospital discharge, an expected 4 days to 4 weeks
Discharge Disposition
Time frame: Patient will be followed until hospital discharge, an expected 4 days to 4 weeks
Ventilator-free days
Time frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Derived from this study: PubMed 26655919Mueller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Eikermann, MD, PhD principal investigator
Massachussetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sarcopenia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical intensive care unit length of stay (time frame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.