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

Peripheral Muscle Strength Clinical Trial

Official title:

Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702000
• Other study ID #: 2008H0081
• Status: Completed
• Phase: N/A
• First received: June 17, 2008
• Last updated: January 15, 2016
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: January 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peripheral Muscle Strength

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Naeem Ali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To determine the acute medical illnesses associated with weakness		duration of ICU stay-up to 10 days	No
Secondary	To determine the modifiable risk factors associated with weakness		duration of ICU stay-up to 10 days	No
Secondary	To determine if there is an association between handgrip strength and ICUAP risk		duration of ICU stay-up to 10 days	No
Secondary	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	No