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

Sponsored by:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00702000

Purpose

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

Condition
Peripheral Muscle Strength

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated 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

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

Contacts

Contact: Janice E Drake, M.D.	614-366-2287	janice.drake@osumc.edu
Contact: Sharon Cheung, B.S.	614-366-2258	sharon.cheung@osumc.edu

Locations

United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Janice E. Drake, CRT 614-366-2287 janice.drake@osumc.edu
Contact: Sharon Cheung, B.S. 614-366-2258 sharon.cheung@osumc.edu

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

Naeem A. Ali, M.D.

Ohio State University

More Information

Responsible Party:	The Ohio State University ( Naeem Ali, M.D., Primary Investigator )
Study ID Numbers:	2008H0081
Study First Received:	June 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00702000
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

ICU acquired paresis

Study placed in the following topic categories:

Paresis
Asthenia
Critical Illness

ClinicalTrials.gov processed this record on January 16, 2009