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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Failure
 Other: Early ICU rehabilitation strategies
Other: Usual Care
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • 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.


Enrollment: 100
Study Start Date: July 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care
Usual hospital rehabilitative services
 Other: Usual Care
All typically applied hospital rehabilitative services applied in the usual fashion
Other Name: Usual Hospital Rehabilitative Services
Experimental: Early ICU Rehabilitation Strategy
Early ICU physical therapy will be applied in this arm
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707303

Locations
United States, North Carolina
Wake Forest School of Medicine
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Peter E. Morris, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Peter E. Morris, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01707303     History of Changes
Other Study ID Numbers: IRB00000240
Study First Received: October 10, 2012
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
ICU
Critical Care
Intensive Care
Critical Illness
Acute Respiratory Failure
 Mechanical Ventilation
Physical Therapy
Strength
Functional Status
Short Physical Performance Battery

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 16, 2013