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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

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 20, 2017
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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+.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03193164 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 19, 2017)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation and Septic Shock
Official Title  ICMJE Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Shock, Septic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: group 1
    Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
    Interventions:
    • Device: Neuromuscular Electrical Stimulation
    • Other: Decubitus Position with the limbs raised to 20º
  • Sham Comparator: group 2
    Decubitus Position with the limbs raised to 20º without NMES and after NMES.
    Interventions:
    • Device: Neuromuscular Electrical Stimulation
    • Other: Decubitus Position with the limbs raised to 20º
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
31
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ada C Gastaldi, PhD 55 16 33153058 ada@fmrp.usp.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03193164
Other Study ID Numbers  ICMJE USP 2017-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ada Clarice Gastaldi, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ada C Gastaldi, PhD Ribeirão Preto Medicine School - University of São Paulo
PRS Account University of Sao Paulo
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP