New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission

Completed

Conditions studied: Muscle Weakness, Critical Illness

In brief

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 regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied. Primary hypothesis: * The development of ICU-associated weakness is independently associated with excess attributable mortality. Secondary hypothesis: * The development of ICU-associated weakness is associated with an increased need for ICU readmission. * Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency * Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.

Key facts

Study ID

NCT00106665

Run by

Naeem Ali, MD

People needed

170

Starts

2005-06-01

Expected to finish

2007-07-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Indiana University Hospitals — Indianapolis, Indiana, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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