Recruiting NA Sepsis

New treatment option for Sepsis

Official title MyokinE100 System: Closed Loop Electrical Muscle Stimulation to Mitigate ICU Acquired Weakness in Medical ICU Patients

ClinicalTrials.gov ID: NCT07362862

What this study is testing

What it's testing
The goal of this clinical trial is to learn if a new medical device that sends electrical signals to the thigh muscles is safe and easy to use for people in the ICU (Intensive Care Unit) who are at risk of losing muscle strength. It will also explore whether this treatment can help slow down muscle weakening.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 85

You may be able to join if

  • Admitted to ER or ICU within the previous 48 hours
  • APACHE II score ≥ 13
  • Meets the criteria for sepsis or severe sepsis

You likely can't join if

  • Anticipated transfer to an ICU not participating in this study
  • Myopathies (e.g. congenital)
  • Acquired myopathies with CK levels 5-times above the upper limit of normal
  • Unable to transfer from bed to chair at baseline
  • Moribund
  • Comfort care
See the full eligibility criteria
Who can join
  • Admitted to ER or ICU within the previous 48 hours
  • APACHE II score ≥ 13
  • Meets the criteria for sepsis or severe sepsis
What rules you out
  • Anticipated transfer to an ICU not participating in this study
  • Myopathies (e.g. congenital)
  • Acquired myopathies with CK levels 5-times above the upper limit of normal
  • Unable to transfer from bed to chair at baseline
  • Moribund
  • Comfort care
  • New onset deep vein thrombosis within the previous 6-months
  • Malignancy in lower limb
  • Technical obstacles - fracture, burns, amputation
  • Open wound or skin abrasion at the garment application site
  • Pregnancy
  • Pacemaker and implantable cardioverter-defibrillator

The study team makes the final eligibility decision.

Where it's taking place

  • Rochester, Minnesota, United States
  • Austin, Texas, United States

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Rochester, Minnesota, United States; Austin, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.