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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
31
The patient will be positioned on a headboard at 30° in the decubitus position with the limbs raised to 20°. The location of the electrical current will be cleared with trichotomy when necessary. Adhesive electrodes 90 x 50 mm will be positioned in the gastrocnemius. The stimulator device will be the Neurodyn II (Ibramed, Sao Paulo, Brazil) to provide symmetrical biphasic pulses of 50 Hz, 250 µsec pulse duration, 2 seconds on (1 second of time of rise and 1 second of time of decay), and 5 seconds of rest during 30 minutes at an intensity capable of generating visible contractions and articular motion.
The patient position will be the same used for intervention protocol (headboard to 30°, decubitus position with the limbs raised to 20°) for 30 minutes, without NMES.
Hospital das Clínicas
Ribeirão Preto, São Paulo, Brazil
Change of counts of Endothelial Progenitor Cells (EPCs)
Change of counts of mobilization of endothelial progenitor cells will be quantified by cytometry markers:+/CD133+/CD45-, CD34+/CD133+/CD45-/VEDFR2 e CD45-/VEGFR2+.
Time frame: 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.
Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE).
Indirect calorimetry is a noninvasive method that analyzes the amount of heat generated. by the whole body according to the substrate utilization. The data provided by calorimetry are: Resting Energy Expenditure (REE) which is calculated from the amount of oxygen consumed (VO2) and carbon dioxide produced (VCO2) through the respiratory gases.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.