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Study of Intensive Care Unit (ICU)-Acquired Weakness (Handgrip Strength Study)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00702000
First Posted: June 19, 2008
Last Update Posted: January 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naeem Ali, MD, The Ohio State University
  Purpose
To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.

Condition
Peripheral Muscle Strength

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study

Further study details as provided by Naeem Ali, MD, The Ohio State University:

Primary Outcome Measures:
  • To determine the feasibility of performing serial assessments of strength (handgrip and limb muscle strength) in a broad population of critically ill patients. [ Time Frame: duration of ICU stay-up to 10 days ]

Secondary Outcome Measures:
  • To determine the acute medical illnesses associated with weakness [ Time Frame: duration of ICU stay-up to 10 days ]
  • To determine the modifiable risk factors associated with weakness [ Time Frame: duration of ICU stay-up to 10 days ]
  • To determine if there is an association between handgrip strength and ICUAP risk [ Time Frame: 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 [ Time Frame: duration of ICU stay-up to 10 days ]

Enrollment: 49
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1.
Those with ICU-acquired weakness

Detailed Description:

We have generated the hypothesis that handgrip strength can be used to develop our understanding of the effects of critical illness on peripheral muscle strength.

To begin to develop this hypothesis, a better understanding of the determinants of handgrip strength needs to be developed. As a result we propose to perform a prospective observational study examining the clinical factors that are associated with handgrip strength. Several clinical factors are known to be associated with increased risk of developing ICUAP while hospitalized: multiple organ failure, severe sepsis, female gender and treatments like steroids. As many of these risk factors are not modifiable, the opportunity to intervene is unclear. However, by attempting to better describe the spectrum of strength deficits experienced by critically ill patients we may better be able to dissect and prevent ICUAP.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects requiring prolonged mechanical ventilation in the ICU
Criteria

Inclusion Criteria:

  • • Adult patients admitted to the Medical ICU

    • Age ≥ 18 years of age at ICU admit.
    • Requiring mechanical ventilation for at least 24 hours

Exclusion Criteria:

  • • 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.
    • Greater than five days since inclusion criteria met.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702000


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Naeem Ali, MD
Investigators
Principal Investigator: Naeem A. Ali, M.D. Ohio State University
  More Information

Responsible Party: Naeem Ali, MD, Associate Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00702000     History of Changes
Other Study ID Numbers: 2008H0081
First Submitted: June 17, 2008
First Posted: June 19, 2008
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by Naeem Ali, MD, The Ohio State University:
ICU acquired paresis