Shock, SepticNCT03193164

Neuromuscular Electrical Stimulation and Septic Shock

A study testing Neuromuscular Electrical Stimulation and Decubitus Position with the limbs raised to 20º in people with Shock, Septic, run by University of Sao Paulo at 1 site in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Shock, Septic
What is being tested?: Neuromuscular Electrical Stimulation and Decubitus Position with the limbs raised to 20º
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteBrazil
Study dates: 13 Nov 2018to 29 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital das Clínicas
Ribeirão Preto, São Paulo, 14049-900

Other trials in Brazil

About this study

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

Read the 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.

Conditions: Shock, Septic
Being tested: Neuromuscular Electrical Stimulation, Decubitus Position with the limbs raised to 20º
Keywords: Electric Stimulation Therapy; Endothelial Progenitor Cells.
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neuromuscular Electrical StimulationDevice
Also called Functional 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.
Decubitus Position with the limbs raised to 20ºOther
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 groups in NCT03193164
Study group	Role	What they receive
group 1	Experimental	Neuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES. Receives: 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. Receives: Device: Neuromuscular Electrical Stimulation; Other: Decubitus Position with the limbs raised to 20º

What is being measured

The primary outcome is the main question the study is designed to answer.

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+.
Measured: 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).
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201829 Jan 2021

First posted20 Jun 2017
Study start13 Nov 2018
Primary completion8 Jan 2020
Study completion29 Jan 2021 (estimated)

Why it stopped: This study had to be suspended due to COVID-19 Pandemic.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Shock, SepticStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This study will be randomized crossover clinical trial.
Masking: Single blind
Who is masked: Investigator
Enrolment: 31 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03193164
Sponsor's protocol ID: USP 2017-1
Status last verified: Feb 2021
First submitted: 5 Jun 2017
Last updated: 5 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification, will be available

Publications

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.
PubMed 26903338
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.
PubMed 26969168
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.
PubMed 17446880
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.
PubMed 22343557
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.
PubMed 35176099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis

All Shock, Septic trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Patients With Septic Shock: a Randomised Crossover Clinical Trial Protocol.
ClinicalTrials.gov ID: NCT03193164
Acronym / sponsor ID: USP 2017-1
Conditions: Shock, Septic
Keywords: Electric Stimulation Therapy; Endothelial Progenitor Cells.
Study type: Interventional
Recruitment status: SuspendedReason stopped: This study had to be suspended due to COVID-19 Pandemic.
Enrolment: 31 participants (estimated)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Study start: 13 Nov 2018 (actual)
Primary completion: 8 Jan 2020 (actual)
Study completion: 29 Jan 2021 (estimated)
First posted: 20 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will investigate the effects of neuromuscular electrical stimulation (NMES) in patients with septic shock.

The results of this study will allow better understanding of the effects of NMES in patients with septic shock.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2
Model description: This study will be randomized crossover clinical trial.

Arm	Type	Receives
group 1	Experimental	Device: Neuromuscular Electrical Stimulation, Other: Decubitus Position with the limbs raised to 20ºNeuromuscular Electrical Stimulation (NMES) and after decubitus position with the limbs raised without NMES.
group 2	Sham comparator	Device: Neuromuscular Electrical Stimulation, Other: Decubitus Position with the limbs raised to 20ºDecubitus Position with the limbs raised to 20º without NMES and after NMES.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neuromuscular Electrical StimulationAlso: Functional Electrical StimulationThe 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.	Device	group 1, group 2
Decubitus Position with the limbs raised to 20ºThe 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.	Other	group 1, group 2

Primary outcome

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+.

1 secondary outcome

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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Background: PubMed 26903338Singer 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.
Background: PubMed 26969168Stefanou 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.
Background: PubMed 17446880Duda 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.
Background: PubMed 22343557Fadini 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.
Derived from this study: PubMed 35176099Lago 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.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, will be available

Related trials for Shock, Septic

Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ada C Gastaldi, PhD principal investigator

Ribeirão Preto Medicine School - University of São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation and Decubitus Position with the limbs raised to 20º in people with Shock, Septic, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03193164, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.