Clinical trial NCT01363102: Systematic Team Approach to Guide Early Mobilization in Surgical Intensive Care Unit Patients
Official title: Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness
Critical Illness
Respiratory Insufficiency
Keywords: Muscle strength
functional mobility
outcome
intensive care unit
quality of life
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: University of Massachusetts, Worcester
name: Technical University of Munich
name: University of Salzburg
First posted: 2011-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or greater)
* Who have been on mechanical ventilation for less than 48 hours and are expected to continue for at least 24 more hours
* Who meet criteria for baseline functional independence (Barthel Index greater than or equal to 70 obtained from a proxy describing patient function 2 weeks before admission

Exclusion Criteria:

* Irreversible disorders with 6-month mortality greater than 50%
* Rapidly developing neuromuscular disease
* Cardiopulmonary arrest
* Motor component of Glascow Coma Scale \<5
* Elevated intracranial pressure
* Ruptured/leaking aortic aneurysm
* Acute MI before peak troponin has been reached
* Absent lower limbs
* Pregnancy
* Unstable fractures contributing to likely immobility
* Hospitalization prior to ICU admission \>5 days
* Enrollment in another clinical trial

Primary outcomes:
measure: Average achieved SOMS level
timeFrame: 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).
Secondary outcomes:
measure: SICU length of stay
timeFrame: Patients will be followed until SICU discharge, an expected 2 days to 2 weeks
measure: The "mini" modified Functional Independence Measure (mmFIM) level
timeFrame: mmFIM will be measured twice, at ICU discharge readiness and hospital discharge readiness, an expected average of one to two and three weeks, respectively.
measure: Quality of life following hospital discharge
timeFrame: three months after hospital discharge
measure: Muscle strength
timeFrame: ICU and hospital discharge readiness, an expected time of one to two and three weeks, respectively.
measure: Side effects of mobilization therapy
timeFrame: during and 30 minutes after mobilization therapy during SICU stay, approximately 1 to 2 weeks.
measure: Genetic Polymorphisms as related to the other outcomes
timeFrame: 5 minutes to collect sample
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Salzburg
country: Austria
facility: University of Salzburg
city: München
country: Germany
facility: Technische Universität München
state: Bavaria
Study officials:
affiliation: The Massachusetts General Hospital
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasotakis G, Schmidt U, Perry D, Grosse-Sundrup M, Benjamin J, Ryan C, Tully S, Hirschberg R, Waak K, Velmahos G, Bittner EA, Zafonte R, Cobb JP, Eikermann M. The surgical intensive care unit optimal mobility score predicts mortality and length of stay. Crit Care Med. 2012 Apr;40(4):1122-8. doi: 10.1097/CCM.0b013e3182376e6d.
citation: Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.
citation: Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.