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Trial record 2 of 3 for:    22067629 [PUBMED-IDS]

Effects of Mobility Dose in Surgical Intensive Care Unit Patients (MQS)

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ClinicalTrials.gov Identifier: NCT03196960
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
Technische Universität München
Università degli Studi di Brescia
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief Summary:
The primary aim of this study is to assess if the mobility dose that patients receive in the surgical intensive care unit (SICU) predicts adverse discharge disposition (primary endpoint), and muscle wasting diagnosed by bedside ultrasound (secondary endpoint).

Condition or disease
Sarcopenia Muscle Weakness Critical Illness

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Mobility Dose in Surgical Intensive Care Unit Patients on Adverse Discharge Disposition
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse Hospital Discharge Disposition [ Time Frame: Patient will be followed until hospital discharge, an expected 3 to 30 days ]
    Adverse hospital discharge is defined as discharge to facilities providing long-term care assistance for daily activities, including nursing homes and skilled nursing facilities, hospice at the patient's home, hospice in a health care facility, or in-hospital mortality.


Secondary Outcome Measures :
  1. Rectus Femoris Muscle Cross Sectional Area [ Time Frame: Rectus femoris cross sectional area will be measured twice, at enrollment and day of ICU discharge, an expected 3 to 30 days. ]
    Rectus femoris cross sectional area will be measured by bedside ultrasound

  2. Mobility Dose as measured by the Mobilization Quantification Score (MQS) [ Time Frame: Patients will be followed until SICU discharge, an expected 3 to 30 days. ]
    Mobilization Quantification Score (MQS) is a composition of the validated ICU mobility score, a 0 to 10 value scale that measures the mobility milestones in critically ill patients, multiplied by a for each level previously defined time unit (5 or 30 minutes correspond to one unit).

  3. Abbreviated Functional independence measure (FIM) score at Surgical Intensive Care Unit (SICU) discharge and hospital discharge [ Time Frame: Patients will be followed until hospital discharge an expected 3 to 40 days. ]
    Abbreviated FIM score obtained by physical therapy (PT) within 48 hours of discharge, and by research assistant on the day of discharge if the subject was not seen by PT in the indicated time period.

  4. SICU length of stay [ Time Frame: Patients will be followed until SICU discharge, an expected 3 to 30 days. ]
    Number of days from SICU admission to SICU discharge

  5. Hospital length of stay [ Time Frame: Patients will be followed until hospital discharge an expected 3 to 40 days. ]
    Number of days from hospital admission to hospital discharge

  6. SICU Ventilator-free days [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of days spent on the SICU that patient is not receiving mechanical ventilation.

  7. SICU Vasopressor-free days [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of days spent on the SICU that patient is not receiving any vasopressor medications.

  8. SICU Delirium-free days [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Days spent on the SICU that patient is Confusion assessment method (CAM)-ICU/Richmond Agitation-Sedation Scale (RASS) negative.

  9. SICU Neuromuscular Blocking drug-free days [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of days spent on the ICU that patient is not receiving Neuromuscular Blocking Agents

  10. Opioid Use [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Opioid dose administered, calculated as morphine equivalent dose.

  11. Corticosteroid Days [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of day on ICU with corticosteroid administration Number of day on ICU with corticosteroid administration Number of ICU days with corticosteroid administration

  12. Physical Work Capacity [ Time Frame: Measured three months after hospital discharge ]
    Obtained after hospital discharge, measured by the Duke Activity Status Index (DASI)

  13. 3-Month Mortality [ Time Frame: Evaluated three months after hospital discharge ]
  14. Falls [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of Falls during ICU stay

  15. Side effects of mobilization therapy [ Time Frame: Patients will be followed until ICU discharge, an expected 3 to 30 days. ]
    Number of unfavorable signs and symptoms or unintended deterioration of clinical status associated with mobilization therapy, including, but not limited to, unplanned extubation or dislodgment of drains, arterial catheters, venous devices, or other medical equipment. The relationship of any untoward event to mobilization therapy was assessed by the clinician and reported as unrelated, unlikely, possibly, or definitely related. Adverse events (AE) were also categorized by intensity as mild, moderate, or severe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients recovering in an intensive care unit following a trauma or a surgical procedure
Criteria

Inclusion Criteria:

  • Adults (18 years of age or greater)
  • Barthel score ≥70 from a proxy describing patient function 2 weeks before admission
  • Expected stay on the ICU of >=3 days

Exclusion Criteria:

  • Patients transferred from other hospitals, long-term rehabilitation facilities or nursing homes with a preceding stay of more than 48 hours
  • Hospitalization 1 month prior to ICU admission >7 days
  • Discussion about changing the goals of care from cure to comfort
  • High risk of persistent brain injury (GCS<5 motor component and presence of TBI)
  • Patients with neurodegenerative diseases
  • Subjects with absence of a lower extremity
  • Patients with paraplegia or tetraplegia
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196960


Contacts
Contact: Matthias Eikermann, MD PhD (617) 726-3030 meikermann@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Matthias Eikermann, MD PhD         
Germany
Klinikum Rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Stefan Schaller, MD         
Italy
Università degli Studi di Brescia Recruiting
Brescia, Lombardy, Italy, 25123
Contact: Nicola Latronico, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Technische Universität München
Università degli Studi di Brescia
Investigators
Principal Investigator: Matthias Eikermann, MD PhD Massachusetts General Hospital

Study Data/Documents: Scoring Sheet  This link exits the ClinicalTrials.gov site
Mobilization Quantification Score

Publications:

Responsible Party: Matthias Eikermann, Associate Professor of Anaesthesia, Harvard Medical School; Clinical Director, Critical Care Division, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03196960     History of Changes
Other Study ID Numbers: 2016P002045
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
Mobilization Therapy
Critical Illness
Muscle Strength
Functional Mobility
Outcome
Intensive Care Unit
Quality of Life

Additional relevant MeSH terms:
Critical Illness
Sarcopenia
Muscle Weakness
Paresis
Disease Attributes
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases