New Onset Weakness in Critically Ill Patients and the Risk of Death and Recurrent ICU Admission

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naeem Ali, MD, Ohio State University
ClinicalTrials.gov Identifier:
NCT00106665
First received: March 28, 2005
Last updated: March 21, 2013
Last verified: March 2013
  Purpose

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.

Condition
Muscle Weakness
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intensive Care Unit(ICU)-Acquired Paresis and the Risk for Mortality and Recurrent ICU Admission (Weakness and ICU Readmission Evaluation-WIRE)

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: during hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrent respiratory failure [ Time Frame: hospitalization ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: June 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically ill patients requireing mechanical ventilation

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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]
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106665

Locations
United States, Indiana
Indiana University Hospitals
Indianapolis, Indiana, United States, 46202
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Naeem A Ali, MD Ohio State University
  More Information

No publications provided by Ohio State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naeem Ali, MD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00106665     History of Changes
Other Study ID Numbers: 2004H0255
Study First Received: March 28, 2005
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
ICU acquired weakness
Critical care polyneuropathy
Critical care myopathy

Additional relevant MeSH terms:
Critical Illness
Asthenia
Muscle Weakness
Paresis
Disease Attributes
Pathologic Processes
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014