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ICU (Intensive Care Unit)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission - Article


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Clinical Trial: ICU (Intensive Care Unit)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission

This study is not yet open for patient recruitment.

Sponsored by: Ohio State University
Information provided by: Ohio State University

Purpose

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.

Condition
Muscle Weakness
Critical Illness

MedlinePlus related topics:  Muscle Disorders;   Neurologic Diseases

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: ICU-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)

Further Study Details: 

Expected Total Enrollment:  200

Study start: April 2005;  Expected completion: August 2006
Last follow-up: April 2006;  Data entry closure: April 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Location Information


Ohio
      The Ohio State University, Columbus,  Ohio,  43210,  United States
Naeem A Ali, MD  614-293-4925    ali-1@medctr.osu.edu 
Naeem A Ali, MD,  Principal Investigator

More Information

Study ID Numbers:  2004H0255
Record last reviewed:  March 2005
Last Updated:  March 28, 2005
Record first received:  March 28, 2005
ClinicalTrials.gov Identifier:  NCT00106665
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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