Shock, Septic
Conditions
Keywords
Electric Stimulation Therapy; Endothelial Progenitor Cells.
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.
Interventions
DEVICENeuromuscular Electrical Stimulation
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.
OTHERDecubitus Position with the limbs raised to 20º
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The blood samples will be mask analyses
Intervention model description
This study will be randomized crossover clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of counts of Endothelial Progenitor Cells (EPCs) | 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 counts of mobilization of endothelial progenitor cells will be quantified by cytometry markers:+/CD133+/CD45-, CD34+/CD133+/CD45-/VEDFR2 e CD45-/VEGFR2+. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE). | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of hemodynamic and respiratory variables | 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. | It will be measured heart rate, blood pressure, oxygen saturation and breathing frequency. |
| Change of Cirtometry | Patients will be measured at the first, the third and the seventh day | Measurements of the circumference of the gastrocnemius muscle. |
Countries
Brazil
Outcome results
None listed