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Neuromuscular Electrical Stimulation and Septic Shock

Primary Purpose

Shock, Septic

Status

Suspended

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Neuromuscular Electrical Stimulation

Decubitus Position with the limbs raised to 20º

About this trial

This is an interventional treatment trial for Shock, Septic focused on measuring Electric Stimulation Therapy; Endothelial Progenitor Cells.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital das Clínicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

group 1

group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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+.

Secondary Outcome Measures

Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE).

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.

Full Information

NCT ID

NCT03193164

First Posted

June 5, 2017

Last Updated

February 2, 2021

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03193164

Brief Title

Neuromuscular Electrical Stimulation and Septic Shock

Official Title

Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Suspended

Why Stopped

This study had to be suspended due to COVID-19 Pandemic.

Study Start Date

November 13, 2018 (Actual)

Primary Completion Date

January 8, 2020 (Actual)

Study Completion Date

January 29, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Septic

Keywords

Electric Stimulation Therapy; Endothelial Progenitor Cells.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study will be randomized crossover clinical trial.

Masking

Investigator

Masking Description

The blood samples will be mask analyses

Allocation

Randomized

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group 1

Arm Type

Experimental

Arm Description

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

Arm Title

group 2

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Neuromuscular Electrical Stimulation

Other Intervention Name(s)

Functional Electrical Stimulation

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Decubitus Position with the limbs raised to 20º

Intervention Description

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 Measure Information:

Title

Change of counts of Endothelial Progenitor Cells (EPCs)

Description

Change of counts of mobilization of endothelial progenitor cells will be quantified by cytometry markers:+/CD133+/CD45-, CD34+/CD133+/CD45-/VEDFR2 e CD45-/VEGFR2+.

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.

Secondary Outcome Measure Information:

Title

Change of Oxygen consumption (VO2), Carbon dioxide production (VCO2) and Resting energy expenditure (REE).

Description

Time Frame

Other Pre-specified Outcome Measures:

Title

Change of hemodynamic and respiratory variables

Description

It will be measured heart rate, blood pressure, oxygen saturation and breathing frequency.

Time Frame

Title

Change of Cirtometry

Description

Measurements of the circumference of the gastrocnemius muscle.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ada C Gastaldi, PhD

Organizational Affiliation

Ribeirão Preto Medicine School - University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas

City

Ribeirão Preto

State/Province

São Paulo

ZIP/Postal Code

14049-900

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All of the individual participant data collected during the trial, after deidentification, will be available

IPD Sharing Time Frame

The data will be available immediately following publication and for five years.

IPD Sharing Access Criteria

The data will be available from the principal investigator upon reasonable request.

Citations:

PubMed Identifier

26903338

Citation

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.

Results Reference

background

PubMed Identifier

26969168

Citation

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.

Results Reference

background

PubMed Identifier

17446880

Citation

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.

Results Reference

background

PubMed Identifier

22343557

Citation

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.

Results Reference

background

PubMed Identifier

35176099

Citation

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.

Results Reference

derived

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Neuromuscular Electrical Stimulation and Septic Shock

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