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Trial record 13 of 13 for:    24108501 [PUBMED-IDS]

Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery (Catastim 2)

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ClinicalTrials.gov Identifier: NCT02391103
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Arabella Fischer, MD, Medical University of Vienna

Brief Summary:
The purposes of this study are 1) to determine whether neuromuscular electrical stimulation (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time variation of MLT and strength from preoperative day to hospital discharge.

Condition or disease Intervention/treatment Phase
Neuromuscular Electrical Stimulation Intensive Care Unit Acquired Weakness Muscle Wasting Muscle Loss Device: Compex 3 Professional (CefarCompex Medical AB) stimulator Device: sham-stimulation Not Applicable

Detailed Description:

In the amendment of June 2011, a twofold study setting was defined in order to recruit patients not only before, but also after cardiothoracic surgery. In sample A, patients were recruited before surgery. In sample B, patients were recruited after surgery. On postoperative day 1, randomization was performed for sample A and B separately. To ensure balance of the NMES and control groups with respect to disease severity, randomization was stratified by the SAPS II score on the first postoperative day. In the intervention group, the anterior muscles of both thighs were electrically stimulated from the first postoperative day until ICU discharge for a maximum of 14 days. In the control group, the electrodes were applied, but no electricity was delivered.The primary outcomes muscle layer thickness (MLT) and muscle strength were assessed from the first postoperative day to ICU discharge and at hospital discharge. All patients in sample A had an additional assessment of MLT and strength before surgery.

All data are analyzed according to the intention-to-treat principle with no imputation for any missing data. Linear mixed models are used to account for the repeated measurements per patient and to determine any fixed effects on MLT and MRC score.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery. An Ultrasound-Based Randomized Controlled Trial
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: NMES group
Anterior muscles of both thighs were electrically stimulated twice a day (2×30 minutes of NMES with a break of at least 30 minutes between both sessions) 7 days a week during the entire ICU stay but no longer than 14 days, starting on postoperative day 1. Highest tolerable intensity was applied.
Device: Compex 3 Professional (CefarCompex Medical AB) stimulator
NMES

Sham Comparator: Control group
In the control group, the electrodes were applied, connected to the stimulator, but no electricity was delivered.
Device: sham-stimulation
no electricity applied




Primary Outcome Measures :
  1. Muscle layer thickness (MLT) [ Time Frame: on preoperative day, from postoperative day 1 onwards every other ICU day for the duration of the ICU stay (expected average of ICU stay: 7 days) and at day of hospital discharge (expected average of hospital stay: 20 days) ]
    Muscle layer thickness of the anterior muscles of the thigh using two-dimensional B-mode ultrasound

  2. Muscle strength [ Time Frame: on preoperative day, from postoperative day 1 onwards every day for the duration of the ICU stay (expected average of ICU stay: 7 days), at day of hospital discharge (expected average of hospital stay: 20 days) ]
    Muscle strength using Medical Research Council (MRC) score and hand dynamometry


Secondary Outcome Measures :
  1. JAGS score [ Time Frame: on preoperative day, on day of ICU discharge (expected average of ICU stay: 7 days), on day of hospital discharge (expected average of hospital stay: 20 days) ]
    JAGS score

  2. Timed Up and Go test [ Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) ]
    Timed Get Up and Go test

  3. FIM score [ Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) ]
    Functional Independance Measure (FIM) score

  4. SF-12 score [ Time Frame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days) ]
    12-item Short Form Health Survey (SF-12)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients before/after cardiothoracic surgery
  • ICU stay > 48 hours

Exclusion Criteria:

  • body mass index > 40 kg/m2
  • severe leg swelling
  • implanted ventricular assist device (RVAD, LVAD, BiVAD)
  • implanted intra-aortic balloon pump (IABP)
  • neuromuscular diseases
  • skin lesions in stimulation area
  • leg excluded if implant (hip or knee replacement) in stimulation area

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): NCT02391103


Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Director: Michael Hiesmayr, MD, Prof. Medical University of Vienna
Principal Investigator: Arabella Fischer, MD Medical University of Vienna

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arabella Fischer, MD, resident, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02391103     History of Changes
Other Study ID Numbers: 1072/2010
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Muscular Atrophy
Critical Illness
Disease Attributes
Pathologic Processes
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical