Study of Intensive Care Unit (ICU)-Acquired Weakness (Han... | NCT00702000

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

NCT00702000

Sponsor

Naeem Ali, MD

Status

Completed

Last Update Posted

Jan 18, 2016Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Peripheral Muscle Strength

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 18, 2008

First Posted Date

Jun 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2016

Last Update Posted Date

Jan 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Label	Type	Description	Intervention Names
1.		Those with ICU-acquired weakness

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
To determine the acute medical illnesses associated with weakness		duration of ICU stay-up to 10 days
To determine the modifiable risk factors associated with weakness		duration of ICU stay-up to 10 days

Other Outcomes

Not provided

Eligibility Module

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.
- Greater than five days since inclusion criteria met.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

subjects requiring prolonged mechanical ventilation in the ICU

Sampling Method

Probability Sample