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

This study has been terminated.
(Insufficient funding)
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00702000
First received: June 17, 2008
Last updated: May 26, 2010
Last verified: May 2010
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the acute medical illnesses associated with weakness [ Time Frame: duration of ICU stay-up to 10 days ] [ Designated as safety issue: No ]
  • To determine the modifiable risk factors associated with weakness [ Time Frame: duration of ICU stay-up to 10 days ] [ Designated as safety issue: No ]
  • To determine if there is an association between handgrip strength and ICUAP risk [ Time Frame: duration of ICU stay-up to 10 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702000

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

No publications provided

Responsible Party: Naeem Ali, M.D., Primary Investigator, The Ohio State University
ClinicalTrials.gov Identifier: NCT00702000     History of Changes
Other Study ID Numbers: 2008H0081
Study First Received: June 17, 2008
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
ICU acquired paresis

ClinicalTrials.gov processed this record on July 20, 2014