New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission (NCT00106665) | Clinical Trial Compass
CompletedNot Applicable
New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission
United States170 participantsStarted 2005-06
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.