Muscle WeaknessNCT00106665
New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission
An observational study of Muscle Weakness and Critical Illness, run by Naeem Ali, MD at 5 sites in United States.
Trial summary
This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Critical Illness
- How many people
- 170 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2005to Jul 2007
- 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: Critically ill patients requireing mechanical ventilation
Who may be able to join
- Adult (age > or = 18) patients admitted to the Medical ICU
- Respiratory failure requiring mechanical ventilation > or = 5 days
- Reasonable expectation for a subsequent return of mental status
Who cannot join
- Patient's family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment
- Pregnancy
- Admitted to ICU from outside hospital
- New or pre-existing diagnosis causing current neuromuscular weakness
- Profound and uncorrectable hypokalemia or hypophosphatemia [K < 2.5 or P < 1.0 throughout enrollment window]
- Inability to assess muscle strength in more than six muscle groups in at least two extremities [Bilateral amputation (BKA or AKA), severe burns, skin lesions or dressings limiting ability of examiner to access and forcibly resist movement of the patients extremities]
Show all 9Show fewer
- Inability to communicate or follow commands of the examiner [persistent coma, severe MRDD (mental retardation and developmental disabilities) or continuing necessary medication use that impairs consciousness (i.e. narcotics), non-English speaker]
- Concurrent enrollment in another clinical trial involving steroids > 20 mg/day prednisone equivalent for > 3 days, neuromuscular blockade for > 24 hours or any aminoglycosides.
- Prisoner or other subject where legal surrogate decision maker is in question
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals of Cleveland
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
The Ohio State University
Columbus, Ohio, 43210
Indiana University Hospitals
Indianapolis, Indiana, 46202
About this study
Official title: Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied.
Primary hypothesis:
Read more
- The development of ICU-associated weakness is independently associated with excess attributable mortality.
Secondary hypothesis:
- The development of ICU-associated weakness is associated with an increased need for ICU readmission.
- Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency
- Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.
Read the detailed description
Study Overview: This study will enroll patients requiring prolonged mechanical ventilation to identify the presence of newly acquired weakness in the ICU. Eligible patients are those that require the use of mechanical ventilation for greater than or equal to five days, because this is a significant risk factor for weakness. These patients will be enrolled and followed to detect the true relative mortality between weak and strong patients in the ICU.
To identify patients with relevant and significant weakness, this study identifies weakness in patients who survive and return to a state of normal consciousness. As such these patients, once enrolled, need to be screened daily for awakening. Once awake an assessment of peripheral muscle strength will be performed with a standard bedside neuromuscular exam and handgrip manometry.
Initial Data Collection: After consent, demographic information and risk factors for neuromuscular disease for each patient will be recorded. Blood pressure values and other data regarding the subjects' severity of illness will be collected. Any previous use of medicines during the current hospitalization that are associated with the development of weakness will be collected as well. Also any previous history of other chronic disease known to be associated with weakness (e.g. diabetes, immune system deficiency, end-stage liver disease or kidney disease) will be noted.
Screen for awakening (SA):Once daily the patient will be assessed for awakening using a standard (RASS). When the patient awake and able to follow commands they will be assessed for muscle strength exam.
Medical Research Council Strength Exam:The examiner will perform their exam on the first day that the patient is eligible by RASS screening. This same examiner will return at least twenty hours, but no more than forty-eight hours later to perform a repeat exam. The exam will be based on the Medical Research Council standard exam. Functions assessed:Upper extremity: wrist flexion, arm flexion, shoulder abduction. Lower extremity: ankle dorsiflexion, knee extension and hip flexion. Handgrip assessment: On the same day as the MRC exam the patient will be asked to perform a handgrip maneuver using the Jamar® handgrip manometer.
Clinical outcomes:
Ventilator use, Re-intubation, Recurrent ICU admission, Tracheostomy use, ICU Length of Stay and Hospital LOS
- Conditions
- Muscle Weakness, Critical Illness
- Keywords
- ICU acquired weakness, Critical care polyneuropathy, Critical care myopathy
- Medical subject headings
- Muscle Weakness, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: during hospitalization
Secondary outcomes (1)
recurrent respiratory failure
Measured: hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2005 (estimated)
- Study startJun 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 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, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106665
- Sponsor's protocol ID
- 2004H0255
- Status last verified
- Jan 2016
- First submitted
- 28 Mar 2005
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703
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
- Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)
- ClinicalTrials.gov ID
- NCT00106665
- Acronym / sponsor ID
- 2004H0255
- Conditions
- Muscle Weakness, Critical Illness
- Keywords
- ICU acquired weakness, Critical care polyneuropathy, Critical care myopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Naeem Ali, MDUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Mar 2005 (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.
This study seeks to define the morbidity of critical care polyneuropathy and to confirm that this diagnosis is, in fact, independently associated with increased mortality. Secondary information regarding the reasons for ICU readmission in patients with weakness may help in formulating cogent discharge strategies for these patients. Measurement of weakness using handgrip strength may provide a useful surrogate marker for weakness that may be more easily and uniformly applied.
Primary hypothesis:
- The development of ICU-associated weakness is independently associated with excess attributable mortality.
Secondary hypothesis:
- The development of ICU-associated weakness is associated with an increased need for ICU readmission.
- Readmission to the ICU will be a result of the development of recurrent respiratory failure or insufficiency
- Handgrip strength testing will detect ICU-associated weakness with an equivalent sensitivity as the comprehensive bedside muscle strength exam.
Detailed description
Study Overview: This study will enroll patients requiring prolonged mechanical ventilation to identify the presence of newly acquired weakness in the ICU. Eligible patients are those that require the use of mechanical ventilation for greater than or equal to five days, because this is a significant risk factor for weakness. These patients will be enrolled and followed to detect the true relative mortality between weak and strong patients in the ICU.
To identify patients with relevant and significant weakness, this study identifies weakness in patients who survive and return to a state of normal consciousness. As such these patients, once enrolled, need to be screened daily for awakening. Once awake an assessment of peripheral muscle strength will be performed with a standard bedside neuromuscular exam and handgrip manometry.
Initial Data Collection: After consent, demographic information and risk factors for neuromuscular disease for each patient will be recorded. Blood pressure values and other data regarding the subjects' severity of illness will be collected. Any previous use of medicines during the current hospitalization that are associated with the development of weakness will be collected as well. Also any previous history of other chronic disease known to be associated with weakness (e.g. diabetes, immune system deficiency, end-stage liver disease or kidney disease) will be noted.
Screen for awakening (SA):Once daily the patient will be assessed for awakening using a standard (RASS). When the patient awake and able to follow commands they will be assessed for muscle strength exam.
Medical Research Council Strength Exam:The examiner will perform their exam on the first day that the patient is eligible by RASS screening. This same examiner will return at least twenty hours, but no more than forty-eight hours later to perform a repeat exam. The exam will be based on the Medical Research Council standard exam. Functions assessed:Upper extremity: wrist flexion, arm flexion, shoulder abduction. Lower extremity: ankle dorsiflexion, knee extension and hip flexion. Handgrip assessment: On the same day as the MRC exam the patient will be asked to perform a handgrip maneuver using the Jamar® handgrip manometer.
Clinical outcomes:
Ventilator use, Re-intubation, Recurrent ICU admission, Tracheostomy use, ICU Length of Stay and Hospital LOS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients requireing mechanical ventilation
Key inclusion criteria (3 listed)
- Adult (age > or = 18) patients admitted to the Medical ICU
- Respiratory failure requiring mechanical ventilation > or = 5 days
- Reasonable expectation for a subsequent return of mental status
Key exclusion criteria (9 listed)
- Patient's family, physician, or both not in favor of aggressive treatment of patient or presence of an advanced directive to withhold life-sustaining treatment
- Pregnancy
- Admitted to ICU from outside hospital
- New or pre-existing diagnosis causing current neuromuscular weakness
- Profound and uncorrectable hypokalemia or hypophosphatemia [K < 2.5 or P < 1.0 throughout enrollment window]
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
Hospital mortality
Time frame: during hospitalization
1 secondary outcome
recurrent respiratory failure
Time frame: hospitalization
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.
- Derived from this study: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
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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, MD principal investigator
Ohio State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness and Critical Illness, run by Naeem Ali, MD at 5 sites 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 9 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 5 sites 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?
Hospital mortality (time frame: during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00106665, which also lists 1 linked publication.
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.