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Search / Trial NCT02247895

Treatment of Muscle Weakness in Critically Ill Patients

Launched by GERALD SUPINSKI · Sep 23, 2014

Trial Information

Current as of August 11, 2025

Terminated

Keywords

Icu Acquired Weakness Critical Illness Mechanical Ventilation

ClinConnect Summary

The basic study design is to:

1. Obtain informed consent from patient or the patients LAR
2. Randomize subjects to treatment with either:

1. Sham therapy, consisting of bilateral placement of Niveus Medical Muscle Stimulation System 110 electrodes for 30 minutes twice daily without activation of the electrical circuitry of the unit, or
2. Active therapy, using the Niveus Medical Muscle Stimulation System 110 electrodes to actively produce a rhythmic quadriceps contraction for 30 minutes twice daily
3. Measure magnetic stimulated quadriceps twitch (QuadTw) strength bilaterally as wel...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Acute respiratory failure requiring mechanical ventilation
  • Exclusion Criteria:
  • Attending physician on service determines that patient too unstable to tolerate measurements
  • Patient requires \> 15mcg/min norepinephrine or \> 15mg/kg/min of dopamine.
  • Fraction of inspired oxygen \> 80% or positive end expiratory pressure \> 15 cm H20 requirements.
  • Cardiac pacemaker or implanted defibrillator.
  • Neuromuscular blocking agents delivered within 48 hours of preceding testing.
  • Existing neuromuscular disease.
  • Profound uncorrectable hypokalemia (\< 2.5) OR hypophosphatemia (\< 1.0)
  • Acute lower extremity deep vein thrombosis
  • Pregnancy
  • Prisoner
  • Institutionalized patient
  • If primary attending determines that patient is terminal and will likely have care withdrawn within 7 days
  • Do not resuscitate order
  • Body mass index \> 40
  • Patients requiring mechanical ventilation more than 4 days prior to study entry

About Gerald Supinski

Gerald Supinski is a dedicated clinical trial sponsor with a commitment to advancing medical research and innovation. With extensive experience in the pharmaceutical and biotechnology sectors, he focuses on developing and managing clinical studies that prioritize patient safety and efficacy. His leadership emphasizes collaboration with healthcare professionals and regulatory bodies to ensure compliance and ethical integrity throughout the research process. By fostering an environment of scientific excellence, Gerald Supinski aims to contribute significantly to the development of new therapies and improve health outcomes for diverse patient populations.

Locations

Lexington, Kentucky, United States

Lexington, Kentucky, United States

Patients applied

0 patients applied

Trial Officials

Gerald S. Supinski, MD

Principal Investigator

Professor of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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