Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients (mSOMS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01363102 |
Recruitment Status
: Unknown
Verified March 2016 by Matthias Eikermann, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted
: June 1, 2011
Last Update Posted
: March 17, 2016
|
Sponsor:
Massachusetts General Hospital
Collaborators:
Beth Israel Deaconess Medical Center
University of Massachusetts, Worcester
Technische Universität München
University of Salzburg
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | May 23, 2011 | |||
First Posted Date ICMJE | June 1, 2011 | |||
Last Update Posted Date | March 17, 2016 | |||
Study Start Date ICMJE | June 2011 | |||
Actual Primary Completion Date | July 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Average achieved SOMS level [ Time Frame: Average SOMS level from time to inclusion to ICU discharge readiness, an expected time of one to two weeks (expected time of one to two weeks). ] Achieved SOMS level will be assessed daily and average values be taken for comparison between groups.
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01363102 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
|
|||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients | |||
Official Title ICMJE | Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients | |||
Brief Summary | The investigators hypothesize that by applying a validated algorithm to accomplish early mobilization in surgical intensive care unit (ICU) patients, these patients will achieve a higher level of mobility which translates to shorter ICU length of stay and improved functional status at discharge. Additionally, the investigators hypothesize that genetic polymorphisms related to muscle strength and sleep will also explain some variance in these outcome variables. | |||
Detailed Description | The trauma literature consistently shows that early mobilization improves patients' outcome after a localized trauma such as hip fracture, or blunt solid organ injuries. In addition, in critically ill patients on the medical ICU, early mobilization improves patients' functional outcome and decreases ICU length of stay (1). This study evaluates if critically ill patients in a surgical ICU can safely and effectively be mobilized early after trauma and surgery. The investigators propose to conduct a randomized controlled study in surgical intensive care unit patients to evaluate the effects of mSOMS guided early mobilization. Additionally, the study will examine known genetic polymorphisms as related to sleep quality and muscle strength and how it relates to early mobilization of surgical ICU patients. In particular, the study will focus on the following polymorphisms: CLOCK, NPAS2, PER2 and PER3, PDE4D,MUC1, ATP2B1, DCDC5, TRPM6, SHROOM3, and MDS1 genes. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Procedure: SOMS
Apply a number to mobilization goal for patient
Other Name: Early Mobilization |
|||
Study Arms |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
200 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Estimated Study Completion Date | December 2016 | |||
Actual Primary Completion Date | July 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 85 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Germany, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01363102 | |||
Other Study ID Numbers ICMJE | 11112010 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Matthias Eikermann, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE |
|
|||
Investigators ICMJE |
|
|||
PRS Account | Massachusetts General Hospital | |||
Verification Date | March 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |