Peripheral Muscle StrengthNCT00702000
Study of Intensive Care Unit (ICU)-Acquired Weakness (Handgrip Strength Study)
An observational study of Peripheral Muscle Strength, run by Naeem Ali, MD at 1 site in United States.
Trial summary
To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Muscle Strength
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects requiring prolonged mechanical ventilation in the ICU
Who may be able to join
- • Adult patients admitted to the Medical ICU
- Age ≥ 18 years of age at ICU admit.
- Requiring mechanical ventilation for at least 24 hours
Who cannot join
- • 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study
To better understand ICU-acquired weakness in patients requiring mechanical ventilation in the Intensive Care Unit.
Read the 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
- Keywords
- ICU acquired paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. | Those with ICU-acquired weakness |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of performing serial assessments of strength (handgrip and limb muscle strength) in a broad population of critically ill patients.
Measured: duration of ICU stay-up to 10 days
Secondary outcomes (4)
To determine the acute medical illnesses associated with weakness
Measured: duration of ICU stay-up to 10 days
To determine the modifiable risk factors associated with weakness
Measured: duration of ICU stay-up to 10 days
To determine if there is an association between handgrip strength and ICUAP risk
Measured: duration of ICU stay-up to 10 days
To generate a set of normative data for handgrip strength in critically ill patients adjusting for important non-modifiable risk factors
Measured: duration of ICU stay-up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naeem Ali, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naeem Ali, MD, Ohio State University
- Investigators
- Naeem A. Ali, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702000
- Sponsor's protocol ID
- 2008H0081
- Status last verified
- Jan 2016
- First submitted
- 17 Jun 2008
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Determinants of Handgrip Strength in Critically Ill Adults: Pilot Study
- ClinicalTrials.gov ID
- NCT00702000
- Acronym / sponsor ID
- 2008H0081
- Conditions
- Peripheral Muscle Strength
- Keywords
- ICU acquired paresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Naeem Ali, MDUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | – | –Those with ICU-acquired weakness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects requiring prolonged mechanical ventilation in the ICU
Key inclusion criteria (3 listed)
- • Adult patients admitted to the Medical ICU
Key exclusion criteria (11 listed)
- • Moribund or in the process of withdrawal of life support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
To determine the acute medical illnesses associated with weakness
Time frame: duration of ICU stay-up to 10 days
To determine the modifiable risk factors associated with weakness
Time frame: duration of ICU stay-up to 10 days
To determine if there is an association between handgrip strength and ICUAP risk
Time frame: duration of ICU stay-up to 10 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naeem A. Ali, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Muscle Strength, run by Naeem Ali, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.