Status:
COMPLETED
New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission
Lead Sponsor:
Naeem Ali, MD
Conditions:
Muscle Weakness
Critical Illness
Eligibility:
All Genders
18+ years
Brief Summary
This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regard...
Detailed Description
Study Overview: This study will enroll patients requiring prolonged mechanical ventilation to identify the presence of newly acquired weakness in the ICU. Eligible patients are those that require the ...
Eligibility Criteria
Inclusion
- Adult (age \> or = 18) patients admitted to the Medical ICU
- Respiratory failure requiring mechanical ventilation \> or = 5 days
- Reasonable expectation for a subsequent return of mental status
Exclusion
- Patient's family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment
- Pregnancy
- Admitted to ICU from outside hospital
- New or pre-existing diagnosis causing current neuromuscular weakness
- Profound and uncorrectable hypokalemia or hypophosphatemia \[K \< 2.5 or P \< 1.0 throughout enrollment window\]
- Inability to assess muscle strength in more than six muscle groups in at least two extremities \[Bilateral amputation (BKA or AKA), severe burns, skin lesions or dressings limiting ability of examiner to access and forcibly resist movement of the patients extremities\]
- Inability to communicate or follow commands of the examiner \[persistent coma, severe MRDD (mental retardation and developmental disabilities) or continuing necessary medication use that impairs consciousness (i.e. narcotics), non-English speaker\]
- Concurrent enrollment in another clinical trial involving steroids \> 20 mg/day prednisone equivalent for \> 3 days, neuromuscular blockade for \> 24 hours or any aminoglycosides.
- Prisoner or other subject where legal surrogate decision maker is in question
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00106665
Start Date
June 1 2005
End Date
July 1 2007
Last Update
January 18 2016
Active Locations (5)
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1
Indiana University Hospitals
Indianapolis, Indiana, United States, 46202
2
University of Cincinnati
Cincinnati, Ohio, United States, 45267
3
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
4
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109