Status:
TERMINATED
Treatment of Muscle Weakness in Critically Ill Patients
Lead Sponsor:
Gerald Supinski
Conditions:
Critical Illness
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients who are admitted to the intensive care unit and require mechanical ventilation frequently develop profound respiratory and limb muscle weakness. Studies show that the development of weakness ...
Detailed Description
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 Niv...
Eligibility Criteria
Inclusion
- Acute respiratory failure requiring mechanical ventilation
Exclusion
- 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- If primary attending determines that patient is terminal and will likely have care withdrawn within 7 days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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02247895
Start Date
December 1 2016
End Date
February 1 2018
Last Update
June 22 2020
Active Locations (1)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40586