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History of Changes for Study: NCT00106665
ICU (Intensive Care Unit)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission
Latest version (submitted January 15, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 February 28, 2006 Recruitment Status, Study Status, Contacts/Locations, Study Identification, Study Design, Study Description and Oversight
3 December 27, 2006 Study Status
4 January 4, 2007 Study Status
5 July 20, 2007 Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight
6 March 21, 2013 Study Status, Eligibility, Study Design, Outcome Measures and Sponsor/Collaborators
7 January 15, 2016 Sponsor/Collaborators and Study Status
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Study NCT00106665
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2004H0255
Brief Title: ICU (Intensive Care Unit)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission
Official Title: ICU-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2005
Overall Status: Not yet recruiting
Study Start: April 2005
Primary Completion:
Study Completion: April 2006
First Submitted: March 28, 2005
First Submitted that
Met QC Criteria:
March 28, 2005
First Posted: March 29, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Ohio State University
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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 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.
Detailed Description:
Open or close this module Conditions
Conditions: Muscle Weakness
Critical Illness
Keywords: ICU acquired weakness
Critical care polyneuropathy
Critical care myopathy
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Defined Population
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 200
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations: United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Contact:Contact: Naeem A Ali, MD 614-293-4925 ali-1@medctr.osu.edu
Contact:Principal Investigator: Naeem A Ali, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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