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

NCT00106665 | Completed

• 1 other identifier: 2004H0255
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Muscle Weakness; Critical Illness

Keywords

ICU acquired weakness; Critical care polyneuropathy; Critical care myopathy

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  during hospitalization

Secondary Outcomes (1)

• recurrent respiratory failure

  hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients requireing mechanical ventilation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naeem Ali, MD: lead

Study Sites (5)

Indiana University Hospitals

Indianapolis, Indiana, 46202, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 18511703 DERIVED

MeSH Terms

Conditions

Muscle Weakness; Critical Illness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Disease Attributes

Study Officials

• Naeem A Ali, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2005
• First Posted: March 29, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 18, 2016

Record last verified: 2016-01

Locations

US (5)