Clinical trial NCT02391103: Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Electrical Stimulation
Intensive Care Unit Acquired Weakness
Muscle Wasting
Muscle Loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Muscle layer thickness (MLT)
timeFrame: 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)
measure: Muscle strength
timeFrame: 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)
Secondary outcomes:
measure: JAGS score
timeFrame: 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)
measure: Timed Up and Go test
timeFrame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
measure: FIM score
timeFrame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
measure: SF-12 score
timeFrame: on preoperative day, on day of hospital discharge (expected average of hospital stay: 20 days)
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Michael Hiesmayr, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Medical University of Vienna
name: Arabella Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
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citation: Puthucheary ZA, Phadke R, Rawal J, McPhail MJ, Sidhu PS, Rowlerson A, Moxham J, Harridge S, Hart N, Montgomery HE. Qualitative Ultrasound in Acute Critical Illness Muscle Wasting. Crit Care Med. 2015 Aug;43(8):1603-11. doi: 10.1097/CCM.0000000000001016.
citation: Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
citation: Fischer A, Spiegl M, Altmann K, Winkler A, Salamon A, Themessl-Huber M, Mouhieddine M, Strasser EM, Schiferer A, Paternostro-Sluga T, Hiesmayr M. Muscle mass, strength and functional outcomes in critically ill patients after cardiothoracic surgery: does neuromuscular electrical stimulation help? The Catastim 2 randomized controlled trial. Crit Care. 2016 Jan 29;20:30. doi: 10.1186/s13054-016-1199-3.