Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- University of Sao Paulo
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Change of counts of Endothelial Progenitor Cells (EPCs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The blood samples will be mask analyses
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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 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.
Arms & Interventions
group 1
Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
Intervention: Neuromuscular Electrical Stimulation (Device)
group 1
Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
Intervention: Decubitus Position with the limbs raised to 20º (Other)
group 2
Decubitus Position with the limbs raised to 20º without NMES and after NMES.
Intervention: Neuromuscular Electrical Stimulation (Device)
group 2
Decubitus Position with the limbs raised to 20º without NMES and after NMES.
Intervention: Decubitus Position with the limbs raised to 20º (Other)
Outcomes
Primary Outcomes
Change of counts of Endothelial Progenitor Cells (EPCs)
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 counts of mobilization of endothelial progenitor cells will be quantified by cytometry markers:+/CD133+/CD45-, CD34+/CD133+/CD45-/VEDFR2 e CD45-/VEGFR2+.
Secondary Outcomes
- 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.)
Investigators
Ada Clarice Gastaldi
Principal Investigator
University of Sao Paulo