Clinical trial NCT03193164: Neuromuscular Electrical Stimulation and Septic Shock
Official title: Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Shock, Septic
Keywords: Electric Stimulation Therapy; Endothelial Progenitor Cells.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be randomized crossover clinical trial.
Primary purpose: TREATMENT

Brief summary: The study will investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock.

Detailed description: The study will investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock.

It will be a randomised crossover clinical trial. Thirty-one patients will enrolled.The study will be divided in two phases, the first will be held in the first 72 hours of septic shock and the second after three days of first assessment. Patients will be selected, randomly, to the intervention Protocol (NMES) and control (positioning). After this procedure the patients will be allocated in Group 1 (NMES and control) or group 2 (control and NMES), with a wash-out period of 4 to 6 hours in between .

The main outcome will be the study of mobilization of endothelial progenitor cells (EPCs). The secondary outcome will be the metabolic and hemodynamic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.

The results of this study will allow better understanding of the effects of NMES in patients with septic shock.

Eligibility criteria: Inclusion Criteria:The patients admitted to the intensive care unit will be considered eligible if:

* they present in the first 72 hours the diagnosis of septic shock according to the international consensus definition of septic shock, and
* stable hemodynamics through fluid resuscitation, and
* vasoactive drugs and mechanical ventilation.

Exclusion Criteria:The exclusion criteria will be patients aged less than 18 years and greater than 65 years, pregnant women, brain death, neuromuscular diseases, use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.

* Contraindications for the use of NMES: fractures, burns and skin lesions, systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours), lower limb amputations, cardiac pacemaker, thrombocytopenia less than 20,000/mm3, BMI greater than 35 kg/m2, important lower extremity oedema, agitation and/or signs of pain during the electrical stimulation.
* Contraindications to begin or continue NMES procedure: Mean arterial blood pressure less than 65 mmHg, use of vasopressor \>50% of the maximum dose (dopamine \>12.5 µg/kg per minute; vasopressin \>0.02U/min and norepinephrine \>1 µg/kg per minute), heart rate \<50 or \>140 bpm, arrhythmias with hemodynamic consequences, myocardial ischemia, temperature \<34 or \>39oC, intracranial pressure \>20 cmH2O, decrease in 10% of SpO2 baseline value or \<88% for more than one minute.

Primary outcomes:
measure: Change of counts of Endothelial Progenitor Cells (EPCs)
timeFrame: It will be taken at the baseline and at the end of the each intervention.The data will be collected in two phases, the first will be held in the first 72 hours of septic shock and the second after three days of first assessment.
Secondary outcomes:
measure: Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE).
timeFrame: It will be taken at the baseline and at the end of the each intervention.The data will be collected in two phases, the first will be held in the first 72 hours of septic shock and the second after three days of first assessment.
Other outcomes:
measure: Change of hemodynamic and respiratory variables
timeFrame: It will be taken at the baseline and at the end of the each intervention.The data will be collected in two phases, the first will be held in the first 72 hours of septic shock and the second after three days of first assessment.
measure: Change of Cirtometry
timeFrame: Patients will be measured at the first, the third and the seventh day
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas
state: São Paulo
Study officials:
affiliation: Ribeirão Preto Medicine School - University of São Paulo
name: Ada C Gastaldi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
citation: Stefanou C, Karatzanos E, Mitsiou G, Psarra K, Angelopoulos E, Dimopoulos S, Gerovasili V, Boviatsis E, Routsi C, Nanas S. Neuromuscular electrical stimulation acutely mobilizes endothelial progenitor cells in critically ill patients with sepsis. Ann Intensive Care. 2016 Dec;6(1):21. doi: 10.1186/s13613-016-0123-y. Epub 2016 Mar 11.
citation: Duda DG, Cohen KS, Scadden DT, Jain RK. A protocol for phenotypic detection and enumeration of circulating endothelial cells and circulating progenitor cells in human blood. Nat Protoc. 2007;2(4):805-10. doi: 10.1038/nprot.2007.111.
citation: Fadini GP, Losordo D, Dimmeler S. Critical reevaluation of endothelial progenitor cell phenotypes for therapeutic and diagnostic use. Circ Res. 2012 Feb 17;110(4):624-37. doi: 10.1161/CIRCRESAHA.111.243386.
citation: Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.