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Completed

NCT Number: NCT00702000

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. To determine the acute medical illnesses associated with weakness

    Time frame: duration of ICU stay-up to 10 days

  2. To determine the modifiable risk factors associated with weakness

    Time frame: duration of ICU stay-up to 10 days

  3. To determine if there is an association between handgrip strength and ICUAP risk

    Time frame: duration of ICU stay-up to 10 days

  4. 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

Sponsors and collaborators

Lead sponsor

Naeem Ali, MD

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 19, 2008
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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