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Neuromuscular Electrical Stimulation and Septic Shock

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ClinicalTrials.gov Identifier: NCT03193164
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ada Clarice Gastaldi, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Shock, Septic Device: Neuromuscular Electrical Stimulation Other: Decubitus Position with the limbs raised to 20º Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will be randomized crossover clinical trial.
Masking: Single (Investigator)
Masking Description: The blood samples will be mask analyses
Primary Purpose: Treatment
Official Title: Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: group 1
Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
Device: Neuromuscular 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.
Other Name: Functional Electrical Stimulation

Other: Decubitus 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.

Sham Comparator: group 2
Decubitus Position with the limbs raised to 20º without NMES and after NMES.
Device: Neuromuscular 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.
Other Name: Functional Electrical Stimulation

Other: Decubitus 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE). [ 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. ]
    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 Outcome Measures:
  1. Change of hemodynamic and respiratory variables [ 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. ]
    It will be measured heart rate, blood pressure, oxygen saturation and breathing frequency.

  2. Change of Cirtometry [ Time Frame: Patients will be measured at the first, the third and the seventh day ]
    Measurements of the circumference of the gastrocnemius muscle.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193164


Contacts
Contact: Ada C Gastaldi, PhD 55 16 33153058 ada@fmrp.usp.br

Locations
Brazil
Hospital das Clínicas Recruiting
Ribeirão Preto, São Paulo, Brazil, 14049-900
Contact: Alessandra F. Lago, Msc    +5516992930814    lagoalessandra@yahoo.com.br   
Contact: Anibal Basile-Filho, PhD    +551636022439    abasile@fmrp.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Ada C Gastaldi, PhD Ribeirão Preto Medicine School - University of São Paulo

Publications:
Responsible Party: Ada Clarice Gastaldi, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03193164     History of Changes
Other Study ID Numbers: USP 2017-1
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ada Clarice Gastaldi, University of Sao Paulo:
Electric Stimulation Therapy; Endothelial Progenitor Cells.

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation