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
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- • If primary attending determines that patient is terminal and will likely have care withdrawn within 7 days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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Lexington, Kentucky, United States
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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