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

NCT ID: NCT00702000

Last Updated: 2016-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-05-31

Brief Summary

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

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.

Conditions

Peripheral Muscle Strength

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1.

Those with ICU-acquired weakness

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Naeem Ali, MD

OTHER

Sponsor Role: lead

Responsible Party

Naeem Ali, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Naeem A. Ali, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2008H0081

Identifier Type: -

Identifier Source: org_study_id