Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter E. Morris, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01707303
First received: October 10, 2012
Last updated: October 12, 2012
Last verified: October 2012

October 10, 2012
October 12, 2012
July 2007
July 2009   (final data collection date for primary outcome measure)
Hospital length of stay, days [ Time Frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks. ] [ Designated as safety issue: No ]
Hospital stay measured in days.
Same as current
Complete list of historical versions of study NCT01707303 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure
Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies

This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Respiratory Failure
  • Other: Early ICU rehabilitation strategies
    Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
    Other Name: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.
  • Other: Usual Care
    All typically applied hospital rehabilitative services applied in the usual fashion
    Other Name: Usual Hospital Rehabilitative Services
  • Usual Care
    Usual hospital rehabilitative services
    Intervention: Other: Usual Care
  • Experimental: Early ICU Rehabilitation Strategy
    Early ICU physical therapy will be applied in this arm
    Intervention: Other: Early ICU rehabilitation strategies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
August 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Mechanically ventilated via an endotracheal tube or mask

Exclusion Criteria:

  • Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
  • Cognitive impairment prior to acute ICU illness (non-verbal)
  • Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
  • Acute stroke
  • Body mass index (BMI) >45
  • Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
  • Hip fracture, unstable cervical spine or pathological fracture
  • Mech vent >48 hours prior to transfer from an outside facility
  • Current hospitalization or transferring hospital stay >72 hours
  • CPR on admission, DNR on admission
  • Hospitalization within 30 days prior to admission
  • Cancer therapy within last 6 months
  • Re-admission to ICU within current hospitalization
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01707303
IRB00000240
Yes
Peter E. Morris, Wake Forest University
Wake Forest School of Medicine
Not Provided
Principal Investigator: Peter E. Morris, MD Wake Forest School of Medicine
Wake Forest School of Medicine
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP