Study of Intensive Care Unit (ICU)-Acquired Weakness (Handgrip Strength Study)
Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study
1 other identifier
observational
49
1 country
1
Brief Summary
To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJanuary 18, 2016
January 1, 2016
2 years
June 17, 2008
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the feasibility of performing serial assessments of strength (handgrip and limb muscle strength) in a broad population of critically ill patients.
duration of ICU stay-up to 10 days
Secondary Outcomes (4)
To determine the acute medical illnesses associated with weakness
duration of ICU stay-up to 10 days
To determine the modifiable risk factors associated with weakness
duration of ICU stay-up to 10 days
To determine if there is an association between handgrip strength and ICUAP risk
duration of ICU stay-up to 10 days
To generate a set of normative data for handgrip strength in critically ill patients adjusting for important non-modifiable risk factors
duration of ICU stay-up to 10 days
Study Arms (1)
1.
Those with ICU-acquired weakness
Eligibility Criteria
subjects requiring prolonged mechanical ventilation in the ICU
You may qualify if:
- Adult patients admitted to the Medical ICU
- Age ≥ 18 years of age at ICU admit.
- Requiring mechanical ventilation for at least 24 hours
You may not qualify if:
- Moribund or in the process of withdrawal of life support
- Patient, family or physicians not in favor of continued support until awakening.
- Profound neurologic injury associated with little or no chance of awakening.
- Active consideration of a diagnosis of brain death by treating physicians.
- Known history of chronic neurological disease resulting in muscle weakness in more than two limbs.
- Inability to perform handgrip dynamometry prior to acute illness.
- Subject is a Non-english speaker
- Subject or surrogate unable to provide informed consent.
- ICU stay of greater than 24 hours within the last thirty days or at any point during the current hospitalization
- Greater than seven days of hospital care prior to hospital admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naeem Ali, MDlead
Study Sites (1)
The Ohio State University
Columbus, Ohio, 43210, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Naeem A. Ali, M.D.
Ohio State University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 19, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 18, 2016
Record last verified: 2016-01