Neuromuscular Electrical Stimulation and Septic Shock

NCT03193164 | Suspended DMC

• 1 other identifier: USP 2017-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Septic

Keywords

Electric Stimulation Therapy; Endothelial Progenitor Cells.

Outcome Measures

Primary Outcomes (1)

• 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+.

  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.

Secondary Outcomes (1)

• 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.

Other Outcomes (2)

• 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.

• Change of Cirtometry

  Patients will be measured at the first, the third and the seventh day

Study Arms (2)

group 1

EXPERIMENTAL

Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.

Device: Neuromuscular Electrical Stimulation; Other: Decubitus Position with the limbs raised to 20º

group 2

SHAM COMPARATOR

Decubitus Position with the limbs raised to 20º without NMES and after NMES.

Device: Neuromuscular Electrical Stimulation; Other: Decubitus Position with the limbs raised to 20º

Interventions

Neuromuscular Electrical Stimulation DEVICE

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.

Also known as: Functional Electrical Stimulation

group 1; group 2

Decubitus Position with the limbs raised to 20º OTHER

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.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (5)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Stefanou C, Karatzanos E, Mitsiou G, Psarra K, Angelopoulos E, Dimopoulos S, Gerovasili V, Boviatsis E, Routsi C, Nanas S. Neuromuscular electrical stimulation acutely mobilizes endothelial progenitor cells in critically ill patients with sepsis. Ann Intensive Care. 2016 Dec;6(1):21. doi: 10.1186/s13613-016-0123-y. Epub 2016 Mar 11.

  PMID: 26969168 BACKGROUND

• Duda DG, Cohen KS, Scadden DT, Jain RK. A protocol for phenotypic detection and enumeration of circulating endothelial cells and circulating progenitor cells in human blood. Nat Protoc. 2007;2(4):805-10. doi: 10.1038/nprot.2007.111.

  PMID: 17446880 BACKGROUND

• Fadini GP, Losordo D, Dimmeler S. Critical reevaluation of endothelial progenitor cell phenotypes for therapeutic and diagnostic use. Circ Res. 2012 Feb 17;110(4):624-37. doi: 10.1161/CIRCRESAHA.111.243386.

  PMID: 22343557 BACKGROUND

• Lago AF, Basile-Filho A, de Oliveira AS, de Souza HCD, Dos Santos DO, Gastaldi AC. Effects of physical therapy with neuromuscular electrical stimulation in acute and late septic shock patients: A randomised crossover clinical trial. PLoS One. 2022 Feb 17;17(2):e0264068. doi: 10.1371/journal.pone.0264068. eCollection 2022.

  PMID: 35176099 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Ada C Gastaldi, PhD

  Ribeirão Preto Medicine School - University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The blood samples will be mask analyses
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be randomized crossover clinical trial.

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 20, 2017
• Study Start: November 13, 2018
• Primary Completion: January 8, 2020
• Study Completion: January 29, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available immediately following publication and for five years.
• Access Criteria: The data will be available from the principal investigator upon reasonable request.

Locations

BR (1)